Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to  the countries of Australia, Hungary, and Spain.
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only.  Packaged in 3g Luer Lock syringes.    Used for etching enamel and dentin.
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.
GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Zevex Incorporated (dba Moog Medical Medical Devices Group)
Distribution was nationwide.  There was government and military distribution.  Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.
MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile.      Product Usage:  Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pressure), packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile.     Product Usage:  Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile.      Product Usage:  Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile.      Product Usage:  Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with the MOOG Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile.      Product Usage:  Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile.      Product Usage:  Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
Distributed domestically to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.      Distributed internationally to ALBANIA, ALGERIA, ANTIGUA AND BARBUDA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINIA, BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LAOS, LITHUANIA, MALAYSIA, MALTA, MEXICO, MOROCCO, MYANMAR, NAMIBIA, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA  SUDAN, SURINAME, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UK, UKRAINE, VENEZUELA, VIETNAM, ZIMBABWE
Potential for positional errors following automatic table movement (ATM).
FORMAX ALL STOCK14% 50 lb bag Ingredients Processed Grain By-Products, Roughage Products, Calcium Carbonate, Salt, Ferrous Sulfate, Manganese Oxide, Zinc Oxide, Copper Sulfate, Sodium Selenite, Manganese Sulfate, Calcium Iodate, Cobalt  Carbonate, Mineral Oil, Kaolin, Vitamin A Supplement, Vitamin D3 Supplement and Vitamin E Supplement. Manufactured by ALABAMA FARMERS COOPERATIVE INC. Decatur, Alabama 35601 UPC 7 16374 33145 1
The firm was notified of the death of various animals due to consumption of the product.  They believe the problem is due to the presence of Monensin.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.      Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.
Product was distributed nationwide in the USA.
INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013.
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, Australia, Bahamas, Brazil, Canada, China, Dominican Republic, England, France, Germany, Israel, Japan, South Korea, Lebanon, Malaysia, Mexico, Netherlands, Panama, Singapore, Spain, Switzerland, and Thailand.
Zimmer Segmental System, ZSS Distal Femur.  Sizes as follows:    a. Size B-LT (Item No. 00585001201);    b. Size B-RT (Item No. 00585001202);    c. Size C-LT (Item No. 00585001301);    d. Size C-RT (Item No. 00585001302)    Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.
The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
a. Item No. 00585001201 (Lot Expiration Date Before 07/31/2026);    b. Item No. 00585001202 (Lot Expiration Date Before 07/31/2026);    c. Item No. 00585001301 (Lot Expiration Date Before 08/31/2026);    d. Item No. 00585001302 (Lot Expiration Date Before 07/31/2026)
Versys 6 inch Beaded Full Coat Plus Hip Prosthesis.  Labeled as follows:    a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906);    b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106);    c. VERSYS 6 INCH BEADED FC 22X160MM STD BODY STD NECK (Item No. 00784302206);    d. VERSYS 6 INCH BEADED FC STEM 19X160MM LM (Item No. 00784301936);    e. VERSYS 6 INCH BEADED FC STEM 20X160MM LM (Item No. 00784302036);    f. VERSYS 6 INCH BEADED FC STEM 21X160MM LM (Item No. 00784302136);    g. VERSYS 6 INCH BEADED FC STEM 22X160MM LM (Item No. 00784302236);    h. VERSYS 6 INCH BEADED FC 14X160MM STD BODY STD NECK (Item No. 00784301406);    i. VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK (Item No. 00784301506);    j. VERSYS 6 INCH BEADED FC 16X160MM STD BODY STD NECK (Item No. 00784301606);    k. VERSYS 6 INCH BEADED FC 17X160MM STD BODY STD NECK (Item No. 00784301706);    l. VERSYS 6 INCH BEADED FC 18X160MM STD BODY STD NECK (Item No. 00784301806);   m. VERSYS 6 INCH BEADED FC 18X160MM STD BODY EXT NECK (Item No. 00784301826);    n. VERSYS 6 INCH BEADED FC 19X160MM STD BODY EXT NECK (Item No. 00784301926);    o. VERSYS 6 INCH BEADED FC 20X160MM STD BODY STD NECK (Item No. 00784302006);    p. VERSYS 6 INCH BEADED FC 20X160MM STD BODY EXT NECK (Item No. 00784302026);    q. VERSYS 6 INCH BEADED FC 21X160MM STD BODY EXT NECK (Item No. 00784302126);    r. VERSYS 6 INCH BEADED FC 22X160MM STD BODY EXT NECK (Item No. 00784302226);    s. VERSYS 6 INCH BEADED FC 17X160MM LM BODY XEXT NECK (Item No. 00784301746);    t. VERSYS 6 INCH BEADED FC 17X160MM LM BODY EXT NECK (Item No. 00784301756  u. VERSYS 6 INCH BEADED FC STEM 18X160MM LM (Item No. 00784301836);    v. VERSYS 6 INCH BEADED FC 18X160MM LM BODY XEXT NECK (Item No. 00784301846);    w. VERSYS 6 INCH BEADED FC 18X160MM LM BODY EXT NECK (Item No. 00784301856);    x. VERSYS 6 INCH BEADED FC 19X160MM LM BODY XEXT NECK (Item No. 00784301946);    y. VERSYS 6 INCH BEADED FC 19X160MM LM BODY EXT NECK (Item No. 00784301956);    z.
a. Item No. 00784301906 (Lot Expiration Date Before 05/31/2025);    b. Item No. 00784302106 (Lot Expiration Date Before 06/30/2025);    c. Item No. 00784302206 (Lot Expiration Date Before 01/31/2026);    d. Item No. 00784301936 (Lot Expiration Date Before 06/30/2026);    e. Item No. 00784302036 (Lot Expiration Date Before 01/31/2026);    f. Item No. 00784302136 (Lot Expiration Date Before 02/28/2025);    g. Item No. 00784302236 (Lot Expiration Date Before 07/31/2026);    h.Item No. 00784301406 (Lot Expiration Date Before 07/31/2026);    i. Item No. 00784301506 (Lot Expiration Date Before 06/30/2026);    j. Item No. 00784301606 (Lot Expiration Date Before 06/30/2026);    k. Item No. 00784301706 (Lot Expiration Date Before 06/30/2026);    l. Item No. 00784301806 (Lot Expiration Date Before 03/31/2026);   m. Item No. 00784301826 (Lot Expiration Date Before 04/30/2026);    n. Item No. 00784301926 (Lot Expiration Date Before 11/30/2025);    o. Item No. 00784302006 (Lot Expiration Date Before 11/30/2025);    p. Item No. 00784302026 (Lot Expiration Date Before 07/31/2026);    q. Item No. 00784302126 (Lot Expiration Date Before 07/31/2026);    r. Item No. 00784302226 (Lot Expiration Date Before 09/30/2025);    s. Item No. 00784301746 (Lot Expiration Date Before 07/31/2026);    t. Item No. 00784301756 (Lot Expiration Date Before 07/31/2025):    u. Item No. 00784301836 (Lot Expiration Date Before 07/31/2026);    v. Item No. 00784301846 (Lot Expiration Date Before 07/31/2026);    w. Item No. 00784301856 (Lot Expiration Date Before 06/30/2026);    x. Item No. 00784301946 (Lot Expiration Date Before 07/31/2026);    y. Item No. 00784301956 (Lot Expiration Date Before 09/30/2025);    z. Item No. 00784302046 (Lot Expiration Date Before 07/31/2026);    aa.Item No. 00784302056 (Lot Expiration Date Before 07/31/2026);    ab. Item No. 00784302146 (Lot Expiration Date Before 07/31/2026);    ac. Item No. 00784302156 (Lot Expiration Date Before 07/31/2026);    ad. Item No. 00784302246 (Lot Expiration Date Before 07/31/2026);    ae.
Product was distributed to various retail distribution centers in the United States  Maryland, Delaware, Virginia, West Virginia, Connecticut, Pennsylvania, New Jersey, New York.
BUTTER MILK ( Under the following Trade Names -  SUNBEAM 2PK, SUNBEAM )
Schmidt Baking Company has decided to initiate a recall of various bread products, after being informed by one of their vendors that the ingredient supplied to them by the vendor is under recall.  Potential of foreign material in product.
POTATO SLAMMERS ( Under the following Trade Names -  SCHMIDT, WHOLE FOODS, HP, WEIS, PLAIN BAG 12 and 24 PK  )
WHITE WHEAT HAMS( Under the following Trade Names -  OT,  WEIS, ULTRA GRAIN )
ALDIS S/T WHEAT BREAD ( Under the following Trade Names -  ALDIS ST WHEAT, HAUSWALD, CHERRY VALLEY, COMPARE, FINEFARE, , HP, KEYFOODS, METFOODS, PIONEER,SUPERA, TRADEFAIR, WEIS, 7 ELEVEN, HAUWALD, GEORGES, REDER )
WHITE S/T DINNERS ( Under the following Trade Names -  HARVEST PRIDE, HARVEST PRIDE 8 COUNT, BLUE RIBBON, GIANT, PLAIN BAG AND ROCKLAND )
BNS WHEAT ROLLS ( Under the following Trade Names - Giant, Harvest Pride, Shoppers and Old Tyme )
LITE HAMS( Under the following Trade Names -  GAINT, SHOPRITE, WEIS)
100 % WHEAT HAMS( Under the following Trade Names -  OT,  GAINT, GOURMET, GRAETVALUE, SHOPRITE , PLAIN BAG )
BUTTER WHITE ( Under the following Trade Names -  O/T, GIANT )
P/L HAMS( Under the following Trade Names -  CHERRY VALLEY, COMPARE, FINEFARE, GIANT, GOURMET, HP, HOLSUM, KEYFOODS, KRASDALE, METFOODS, PIONEER, REDNER, SHOPPERS, SUPERA, SUPERBREAD, TOP TOMATO, TRADEFAIR, WEIS, 7 ELEVEN, HAUWALD, GREAT VALUE, GENERIC, GOURMET 16CT, REDER 16CT, WEIS 16CT, CLOVERVALLEY, COUSINS )
HONEY WHEAT ( Under the following Trade Names -  ALDIS, GOURMET, GAINT, GREATVALUE, 2PK O/T, RENDERS, SUPERBREAD, SHOPRITE, WEIS  )
100 % WHEAT 20 oz ( Under the following Trade Names -  ALDIS, CLOVERVALLEY, GENERIC )
P/L POTATO ( Under the following Trade Names -  WHOLE FOOODS, PLAIN BAG, GIANT, HP, SHOPPERS, SHOPRITE, WEIS )
WHITE WHEAT R/T ( Under the following Trade Names -  O/T 2PK, O/T, WEIS, ULTRA GRAIN )
WHITE WHEAT S/T DINNERS ( Under the following Trade Names -  ULTRA GRAIN, O/T )
POTATO  HAMS( Under the following Trade Names -  OT 16 CT, OT)
PATATO BREAD ( Under the following Trade Names -  O/T 2PK, O/T )
8 GRAIN ( Under the following Trade Names -  INKEEPER )
WHOLE GRAIN WHITE ( Under the following Trade Names -  ALDIS, BLUE RIBBON, GOURMET, SHOPRITE  )
S/T Potato Dinners ( Under the following Trade Names - SCHMIDT O/T, PLAIN BAG -ROYAL FARMS )
Julian code Dates are - 342, 344, and 345
S/T WHEAT ( Under the following Trade Names -  O/T, GIANT, HOLSUM,SHOPPERES, WEIS, GREATVALUE, O/T 2PK )
12 GRAIN ( Under the following Trade Names -  O/T )
PREMIUM WHITE ( Under the following Trade Names -  BLUERIBBON, HOLSUM 2PK, BLUERIBBON 2PK, SUNBEAM, HOLSUM, WEIS )
BNS WHITE ( Under the following Trade Names - Giant, Harvest Pride -Shoprite, Sunbeam, Blueribbon, Shoppers, Weis )
PREMIUM HAMS( Under the following Trade Names -  16CT RIBBON, BLUE RIBBON SUNBEAM, ALDIS)
COSTCO HAMS( Under the following Trade Names -  OT)
Rusch(R) Greenlite MAC 1, Catalog Number 004551001
The pouch may contain the incorrect Rusch  Green Lite product size. Pouches that are labeled as containing RUSCH GREEN LITE MAC 1 may  instead contain RUSCH GREEN LITE MAC 2.
Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,
ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001  in vitro diagnostic
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
ultraView Universal DAB  Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001  in vitro diagnostic
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001  in vitro diagnostic
CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001  in vitro diagnostic
OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001  in vitro diagnostic
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001  in vitro diagnostic
OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001  in vitro diagnostic
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001  in vitro diagnostic
OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001  in vitro diagnostic
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001  in vitro diagnostic
ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001  in vitro diagnostic
ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001  in vitro diagnostic
JustFoodForDogs Beef and Russet Potato;  USDA certified lean ground beef, russet potatoes, sweet potatoes, carrots, green beans, USDA certified beef liver, green peas, apples, Safflower oil, Premium EPA/DHA.  7, 18 and 72 oz. packages, frozen;    7oz (UPC 799471556665);  18oz (UPC 799471556641);  72oz (UPC 799471556757).    JustFoodsForDogs, Loa Alamitos, CA
Consumer complaint initiated testing of dog food was positive for Listeria monocytogenes
JustFoodForDogs Fish and Sweet Potato;  Wild Caught Pacific Cod;  Sweet Potatoes, Russet Potatoes, Green Beans, Broccoli, Safflower oil.  Sold in 7, 18 and 72 oz. packages, frozen.    7oz (UPC 799471556726);  18oz (UPC 799471556702);  72oz (UPC 799471556788)    JustFoodForDogs  Los Alamitos, CA
JustFoodForDogs Turducken:  USDA Certified Ground Turney, USDA Certified Ground Duck Breast, USDA Certified Ground Chicken Thigh; Butternut squash, Green Beans, Safflower Oil.    14 and 72 oz. packages, frozen    Turducken 14oz (UPC 799471558010);  Turducken 72oz (UPC 799471558034).    JustFoodForDogs, Los Alamitos, CA
MEDISTIM VERIQ SYSTEM, MODEL VQ4122    An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
JANUS  & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows.
(Lots 146W to 174W)    Product Usage:  A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.
) has determined that adhesive can be dislodged during the intended use of the cystoscopy bridge or working insert, e.g., when inserting an instrument through the working channel. As a result, a fragment of the adhesive may fall inside the patient's bladder, urethra or uterus and would need to be retrieved, extending the length of the procedure or requiring additional surgical treatment.    The adhesive is used to seal gaps inside the working channel of the cystoscopy bridges and working inserts. In 2013, the adhesive used until then was discontinued and had to be replaced. Current investigations revealed that the durability of the new adhesive is insufficient
Model Numbers and Associated  Lot Numbers: A20975A -- 13-ZW to 172W  A20976A -- 146W to 172W A20977A -- 146W to 174W
AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA  AU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU
OTTO BOCK Kenevo knee joints Model 3C60=ST
Product was shipped to the following states: AZ, OH & TX
Divine Living Tooth Brushing Spray 4oz Active Ingredients: 1% Food Grade Hydrogen Peroxide, Purified water, organic aloe vera, and organic essential oils (peppermint, rosemary, cinnamon, eucalyptus, lemon, orange, and clove) Bryan, Ohio 43506 customerservice@divineliving123.com
The firm was notified by The Ohio Dept. of Agriculture that their products contained dietary and health claims.
Divine Living Silver with harmonically structured frequencies A Wellness Solution 8 oz Ingredients: Structured Water, Pure Silver West Unity, Ohio 419-682-0918
Worldwide distribution.  US nationwide, Austria, Belgium, Bosnia-Herzegovina, Croatia, Finland, France (incl. Guadeloupe, Martinique, Reunion, French Guinea overseas departments), Germany, Greece, Hungary, Italy, Kazakhstan, Macedonia, Latvia, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Argentina, Brazil, El Salvador, Mexico, Peru, Uruguay, Canada, and Australia.
BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and   BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time      Product Usage:  For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.
The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results for expected normal samples, and may recover above the upper limit of normal (< 21 sec.) as stated within the IFU (Instruction For Use).
Manufactured:  BC Thrombin Reagent Kit Lot 46751: 3673 kits  BC Thrombin Reagent Kit Lot 47184: 3958 kits    Total kits Distributed to Customers  Domestic and Foreign:   BC Thrombin Reagent Kit Lot 46751: 3549 kits  BC Thrombin Reagent Kit Lot 47184: 2580 kits    Product Code/ Lot# Date Manufactured Date Expired  46751                  2016-11-01       2018-09-08  47184                  2017-03-20       2019-02-21
Ready-to-Eat Powdered Peanut Butter in 1 lb (16 oz.) plastic jars
Analytical results for generic non-pathogenic  E. coli  surpassed firm's in-house specifications for finished product..
Fresh Fragrant Pear;  Label - Double Trees    Product of China  Shenzhen J.F. Fruit Co., LTD
Firm was notified of unapproved pesticide - isocarbophos, on Fresh Fragrant Pears imported from China and fruit was  released into commerce.
USA (nationwide) Distribution to the states of :  CA, CO, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and  WV; and Internationally to Canada
Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7      Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.
An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
Biofinity XR Toric contact lenses 8.7/14.5 - 6PK      Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters. The Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights /7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing Eye Care Practitioner.
The firm identified a labeling error affecting Made-To-Order  (MTO) Biofinity XR Toric blister labels. The primary blister reads  Biofinity Multifocal Toric  in error, and should read  Biofinity XR Toric.  The outer carton correctly reads  Biofinity XR Toric.
Coated VICRYL RAPIDETM (Polyglactin 910) Suture
On August 17, 2017, Ethicon had decided to initiate a medical device recall  (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture  that were distributed to the field. During finished goods testing, a suture damage was  identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent  investigation, the suture also failed knot tensile strength testing.
Coated VICRYL RAPIDETM  (Polyglactin 910) Suture MPVR4260H Size 4-0 VICRYL RAPIDE  Undyed 75cm PS-2 Needle 10705031149168  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture V2140H Size 4-0 VICRYL RAPIDE  Undyed 70cm RB-1 Needle 10705031106048  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VR2217 Size 2-0 VICRYL RAPIDE  Undyed 90cm V-34 Needle 10705031119925  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VR2253 Size 2-0 VICRYL RAPIDE  Undyed 75cm FS-1 Needle 10705031119956  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VR2279 Size 4-0 VICRYL RAPIDE  Undyed 75cm V-4 Needle 10705031086524  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VR2294 Size 4-0 VICRYL RAPIDE  Undyed 75cm FS-3 Needle 10705031086548  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VR2297 Size 4-0 VICRYL RAPIDE  Undyed 75cm FS-2 Needle 10705031119970  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VR496 Size 4-0 VICRYL RAPIDE  Undyed 18'' PS-2 Needle 10705031134690  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VR945 Size 2-0 VICRYL RAPIDE  Undyed 36'' CT-1 Needle 10705031133358  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VRI253H Size 2-0 VICRYL RAPIDE  Undyed 75cm FS-1 Needle 10705031111172  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture W9941 Size 2-0 VICRYL RAPIDE  Undyed 75cm FS Needle 10705031130999  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VR426 Size 4-0 VICRYL RAPIDE  Undyed 75cm PS-2 Needle 10705031134669  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VR494 Size 4-0 VICRYL RAPIDE  Undyed 45cm P-3 Needle 10705031134683  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VR845 Size 4-0 VICRYL RAPIDE  Undyed 45cm PC-3 Needle 10705031134744  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VR917 Size 2-0 VICRYL RAPIDE  Undyed 90cm V-34 Needle 10705031134768  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VR2286 Size 2-0 VICRYL RAPIDE  Undyed 90cm FSL Needle 10705031080256  Coated VICRYL RAPIDETM  (Polyglactin 910) Suture VR2299 Size 2-0 VICRYL RAPIDE  Undyed 75cm FS-2 Needle 10705031080294  Coated VICRYL
Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI.      Distributed internationally to Canada.
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
Lot No. 1203395, Expiration Date 11/30/2019
Philips Electronics North  America Corporation
Allura Xper FD and and Xper FD ORT - Philips X-ray Systems    Product Usage:  The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for:   Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/15 and Allura Xper FD10/10 is intended for:   Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis.   Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology.   Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally:   The Allura Xper FD series is compatible with a hybrid Operating Room (OR Table)
Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the two gliding rods into an aluminum block of  the support arm can come loose because of vibrations and forces exerted on them.  If the set screws have come loose gravity can keep the rods in position. However, if a force is exerted on the monitor pushing it forward, the monitor can  topple forward. Once the monitor has toppled over it is only attached with its wires. If the monitor breaks loose of its wires it will drop on the floor.
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System    Shunt, central nervous system and components
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage.    Product Usage:  The Allura Xper series is intended for use on human patients to perform:   Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis.   Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP).   Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these products.  Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU.  The overheating may also generate a peculiar burning smell that may be noticed. In some instances this burning smell may be noticed before the ADU fails.  When the ADU fails the X-ray performance of the system is reduced to  Emergency Fluoroscopy. Exposure will not be possible and image quality is reduced.
Heat Seal Pouch 100 pouches per box; 9 boxes per case    Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch.
Self Seal Pouch 100 pouches per box; 6 boxes per case    Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Heat Seal Pouch 100 pouches per box; 5 boxes per case    Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
x100'. One roll per box; 10 boxes per case 10 rolls/cs    Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Self Seal Pouch 200 pouches per box; 4 boxes per case    Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Heat Seal Pouch 200 pouches per box; 5 boxes per case    Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Heat Seal Pouch 200 pouches per box; 5 boxes per case  Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Self Seal Pouch 100 pouches per box; 4 boxes per case    Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
x100'. One roll per box; 10 boxes per case 6 rolls/cs    Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Heat Seal Pouch 200 pouches per box; 4 boxes per case    Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Self Seal Pouch 100 pouches per box; 5 boxes per case    Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
x100'. One roll per box; 10 boxes per case 10 rolls/cs  Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Heat Seal Pouch 100 pouches per box; 4 boxes per case    Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Distributed in 44 states: AL, AK, AZ, AR, CA, CO, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY; Puerto Rico, and the following countries: Algeria, Australia, Azerbaijan, Bahrain, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India,	Israel, Italy, Republic of Korea, Kuwait, Latvia, Malaysia, Mexico,	Morocco, Myanmar, Panama,	Peru, Philippines, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, and Vietnam.
V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
Distributed domestically to AK, AL, AR, AZ, CA, CO, FL, ID, IN, KY, MA, MD, ME, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.      Distributed internationally to ARGENTINA, AUSTRALIA, CANADA, COSTA RICA, JAPAN, NETHERLANDS.
Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
Ziptight Ankle Syndesmosis  Fixation was packaged without the tip protectors.
The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on  the label is 2202-06. The correct expiration date should be 2022-06.
Product was shipped to the following states: FL, MD, NC, NY, OH & PA.
SOUTHERN GROVE ALMONDS Unsalted 14 oz (397g) pouch bag INGREDIENTS: ALMONDS. Distributed by ALDI Inc. Batavia, IL 60510 UPC 0 41498 24647 1
The firm was notified by a customer that Wasabi Soy Almonds were in bags labeled Unsalted Almonds. Wasabi Almonds contains wheat, soy and peanut oil which are not listed in the ingredient statement.
Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
Quantities co-mingled under initial product
The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
Distribution was made to medical facilities nationwide, including government and military distribution.  Foreign distribution was made to Canada, Belgium, China, United Kingdom, UAE, France, Germany, Spain, Japan, Ecuador, and Russia.
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
The mounts on the monitor may have an insufficient (missing or incomplete) weld.
United States and Canada:  Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230; International:  Serial numbers 6145060-O11628 to 6176090-V14102
DePuy Mitek, Inc., a Johnson & Johnson Co.
1113 Gravity Tube Set Pk/24 -SH    Product Usage:  The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Washington, DC, Puerto Rico, and countries of: Lebanon, Panama, Saudi Arabia, Germany, India, and Canada.
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including:  866023 IntelliVue Info Center iX A.0  866117 PIIC Classic Upgrade  866389 IntelliVue Info Center iX B.0, C.0  867141 IntelliVue Info Center iX B.0  866025 IntelliVue Server IX A.0  866118 Database Server Upgrade A.0
Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. Any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the Surveillance station during such restart. Until this issue can be corrected, users should avoid intentionally restarting their Surveillance stations in 2018.
All PIIC iX Surveillance stations including:  866023 IntelliVue Info Center iX A.0  866117 PIIC Classic Upgrade  866389 IntelliVue Info Center iX B.0, C.0  867141 IntelliVue Info Center iX B.0  866025 IntelliVue Server IX A.0  866118 Database Server Upgrade A.0
LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC
US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singapore
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
Presence of bacterial endotoxins levels above the acceptable limit
Cargill, Inc. dba Cargill Feed and Nutrition
Bulk Pelleted Cattle Feed - Genetic Expression 14% Jumpstart (BVT) Medicated; Active Drug Ingredient: Lasalocid 40.00g/ton
Comingling of pelleted cattle feed with unintended swine feed within non-contract 3rd party conveyance
Worldwide Distribution - USA (nationwide) Distribution,  Internationally to Canada.
digital x-ray detector    ProGrade R1 - solid state X ray imager (flat panel/digital imager)    As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for all routine radiographic examinations, including specialist area like intensive care, trauma, or pediatric work, excluding mammography. United States only: The Eleva Workspot is not intended for fluoroscopy and angiography.
It the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may fail to transfer from the SkyPlate detector to the system.  The image remains in the memory of the detector, but cannot be transferred wirelessly or by use of the backup cable. To continue, the operator can reset the SkyPlate detector by removing its batteries, but the acquired image is lost and a  re-take is necessary.
Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.
Phoenix Antegrade Femoral Nail   Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt.  orthopedic instrument
Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
979195 Loaner Kit for femoral intramedullary nail.  Orthopedic instrument.
14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
AccuLIF TL Insertion Handle     The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in the anterior portion of the intervertebral space, and then through activation of the rotational pivot between the Handle and implant for final placement of the crescent-shaped cage across the anterior portion of the disc space. The AccuLIF TL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1.
position, the implant may be able to pivot rather than maintaining a rigid connection.
Raws for Paws Ground Turkey Food for Pets, packaged in 1 lb. or 5 lbs.  chubs in the following package configurations:    1.  Product Code 9900008,  4 - 5 lb. Ground Turkey chubs  Net Wt. 20.00 lbs.  9.07 KG;     2.  Product Code 9900009,  10 - 1 lbs. Ground Turkey chubs, Net Wt. 10.00 lb. 4.54 KG  3.  Product Code 9900014, 5 - 1 lb. chubs of each Turkey, Chicken, and Beef, Net Wt. 15.00 lb 6.80 KG.     4.  Product Code 9900015, 4 - 5 lb. chubs.  1 Turkey, 1 Chicken, and 2 Beef, Net Wt. 20.00 lbs.  9.07 KG;       Keep Frozen.  Not intended for human consumption.  2700 26th Ave. S, Minneapolis, MN  55406
Turkey Pet food was found to be contaminated with Salmonella.
Worldwide Distribution - US Nationwide in the states of: AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, NC, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV and the countries of  Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Pakistan, Russia, Saudi Arabia, Spain, Switzerland, UAE, Uzebekistan
If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup or preparing for a scan.
Distributed in 21 states: AR, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NY, OK, OR, PA, SC, TX, VA, WA, WV.
Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.
The ultrasound probe may not have adequate protection against electrical shock hazards.
Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03
AVID TruCustom SPINE convenience kits, Item Code: LITT016-04
AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04
AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04
AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12
AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02
AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09
AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06
AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06
AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09
AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04
AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01
AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08
AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07
AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02
AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14
AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02
AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02
AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03
AVID TruCustom PACEMAKER PACK  (CARDIOLOGY) convenience kits, Item Code: VAMK016
AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08
Domestic: Meijer stores in Michigan, Ohio, Indiana, Illinois, Kentucky and Wisconsin    No Foreign or VA/DOD
Meijer Greek Yogurt 0% Strawberry 5.3 oz.  The products are packaged in a plastic cup with a foil seal and a label listing the above-mentioned UPCs.
The firm is announcing a voluntary recall of select Meijer branded Greek and Low-fat yogurt as a precautionary measure due to the potential risk of small particles of glass.
Date code for all products: 3/8/2018    7-60236-12418-4     Meijer Greek Yogurt 0% Strawberry 5.3 oz.
Meijer Yogurt Blended Low-fat Blueberry 6 oz.The products are packaged in a plastic cup with a foil seal and a label listing the UPCs.
Date code for all products: 3/8/2018    7-08820-41513-3   Meijer Yogurt Low-fat Blueberry 6 oz.
Meijer Greek Yogurt 0% Plain 5.3 oz.    The products are packaged in a plastic cup with a foil seal and a label listing the UPCs.
Date code for all products: 3/8/2018  7-60236-11601-1        Meijer Greek Yogurt 0% Plain 5.3 oz.
Meijer Greek Yogurt 0% Vanilla 5.3 oz.  The products are packaged in a plastic cup with a foil seal and a label listing the above-mentioned UPCs.
Date code for all products: 3/8/2018  7-60236-11603-5        Meijer Greek Yogurt 0% Vanilla 5.3 oz.
Meijer Greek Yogurt 0% Blueberry 5.3 oz.    The products are packaged in a plastic cup with a foil seal and a label listing the above-mentioned UPCs.
Date code for all products: 3/8/2018    7-60236-12431-3        Meijer Greek Yogurt 0% Blueberry 5.3 oz.
Meijer Greek Yogurt 0% Black Cherry 5.3 oz.  The products are packaged in a plastic cup with a foil seal and a label listing the above-mentioned UPCs.
Date code for all products: 3/8/2018    7-08820-12657-2       Meijer Greek Yogurt 0% Black Cherry 5.3 oz.
The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Worldwide Distribution - US Distribution.
Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card  (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT  system.
Worldwide Distribution - US Nationwide in 33 states: AL, AR, CA, CO, CT, FL, GA, IA, ID, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NM, NY, OH, OK, OR, PA, TN, TX, VA, WA, WI in the countries of Greece, South Africa, France, Germany, Italy, United Kingdom, Sweden, Netherlands, and Dominican Republic.
Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000    Product Usage:  The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses are cleared for use in the US only: Gastrointestinal and Affiliated Organ Surgery including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery including removal of benign or malignant tumors or other unwanted soft tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy.
A faulty footswitch may result in unintended ultrasonic fragmentation activation.  There are two scenarios when the failure mode may occur:  1) Ultrasonic fragmentation may be inadvertently activated at start-up or at the initial use once the footswitch is connected to the console and after the user primes the system, performs a handpiece test, and enters the Main Screen. 2) Ultrasonic fragmentation may remain activated during surgical use once the foot pedal is disengaged slowly.
Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the DHEA (dehydroepiandrosterone) supplement.
A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system.
***PEPITAS***THAI SWEET CHILI ROASTED PUMPKIN KERNELS***Ingredients: organic pumpkin seeds, pure cane sugar, vinegar, sea salt, red chiles, garlic, xanthan gum ***
Pepitas, International Food Court brand, Thai Sweet Chili Roasted Pumpkin Seeds, 4oz. bags, is recalled due to undeclared soybean oil and soy lecithin.
Worldwide Distribution - USA (nationwide) and to the countries of :  United Kingdom & Spain
NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070    Hemodialysis systems and accessories
May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare  product.
direct internet customers nationwide and in Canada.
ZooLogics Chicken Meals for Dogs, Darwin's Natural Pet Products, each package contains 4 /8 oz. quadrants, Net wt: 2 lbs. No UPC.
ZooLogics Chicken Meals for Dogs is recalled due to the potential for contamination with Salmonella.
ZooLogics Duck Meals for Dogs, Darwin's Natural Pet Products, each package contains 4 /8 oz. quadrants, Net wt: 2 lbs. No UPC.
ZooLogics Duck Meals for Dogs is recalled due to the potential for contamination with Salmonella.
Lot # 41957, manufacture date 11/16/2017.
Percutaneous  Gastrojejunostomy  Set    Product Usage:  Intended for the percutaneous placement of a catheter for gastroenteric feeding
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Wills-Oglesby Percutaneous Gastrostomy Set  Product Usage:  Intended for the percutaneous placement of a catheter for gastroenteric feeding
Mallinckrodt Institute Percutaneous  Gastrostomy Set     Product Usage:  Intended for the percutaneous placement of a catheter for gastroenteric feeding
US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201    AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
Product was placed into distribution prior to completion of all required post sterilization release activities.
Lot Number: 5229642; Manufactured 6-Sep-17; Expiration Date: 31-Aug-20
Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
**Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
**Recall expanded to add these models: BBB38, Lot Number: 5300-S19813; BBB38NS, Lot Number: 1707-1 and 170903
Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
Germany, Federal Republic of; Switzerland
Blood products collected from a donor for whom donor suitability was not adequately determined, were distributed.
US Nationwide Distribution in the states of FL, MO, NY, TN
SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618    Product Usage:  Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628    Product Usage:  Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
White Quinoa;  16 oz. (454g) bags with clear panel in front;  UPC: 0 72431 00195 6    Brand name Lunds & Byerlys    Quinoa ingredients: White Quinoa    Couscous ingredients: Israeli Couscous (wheat flour, rosemary extract). Contains: Wheat.    Produced for Lunds & Byerlys, Edina, MN.
Firm was notified by customer that some bags of White Quinoa actually contain Israeli Couscous and therefore do not declare wheat as an ingredient or allergen.
Distributed in XX states: Ak, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, the District of Columbia, Guam, and Puerto Rico.
Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.
Artis zee and Artis zeego model Interventional fluoroscopic x-ray   foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Sourdough Baguette:    Product number 2064; SKU 61659798; GTIN [00046567600949];  UPC 831 49000064    20 pieces;  Ingredients: Unbleached Wheat Flour, Water, Sea Salt, Starter (Fermented dough).    Best Practices:  1. Keep Bread frozen at all times  2. Pull bread out of freezer  3. Preheat oven to 425 degrees F  4. Bake 12-15 minutes with no steam.
Customer reported finding small metal piece similar to a BB on the outside of the bread before baking
Sourdough French:    Product number 2044; SKU 61659799; GTIN [00046567600932] ;  UPC 831 49000044    20 pieces;  Ingredients: Unbleached Wheat Flour, Water, Sea Salt, Starter (Fermented dough).    Best Practices:  1. Keep Bread frozen at all times  2. Pull bread out of freezer  3. Preheat oven to 425 degrees F  4. Bake 12-15 minutes with no steam.
Worldwide Distribution :  Argentina  Australia  France  Italy  Mexico  Poland  Spain  Sweden  Russia  South Korea  Ukraine
Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.
Fresenius Medical Care Renal Therapies Group, LLC
2008T, Hemodialysis Delivery System    Product Indicated for acute and chronic dialysis therapy.
While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.
2008T machines:  190766 2008T Hemodialysis System w/Bibag  190895 2008T GEN 2 Bibag without CDX    190766 = 00840861100910 (+Serial Number)  190895 = 00840861100927 (+Serial Number)ux=&Su
Product was distributed to one specialty pharmacy distributor in the US  Walgreens Specialty Pharmacy  16287, 130 Enterprise Drive  Pittsburgh, PA 15275    Foreign Account: Italy
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
Models EMV+, AEV, Eagle II,and Eagle II MRI
Worldwide Distribution - US Nationwide Distribution and in the countries of  Canada.
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000.    Product Usage:  Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. The Chromophare surgical lights consist of a ceiling tube, SK Box swivel arm support, and a light head. The light head is mounted on a cardanic suspension unit and can be turned, swiveled and tilted in any direction. The spatial repositioning of the light head makes use of the 360 degree rotating swivel/horizontal arm. The 360 degree rotating spring arm is used to adjust the height. The light can be mounted in several configurations, such as a single/dual ceiling mount, a boom-integrated suspension mount, a wall mount, or a mobile roll stand.
The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling.
SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120
a) 1007 bottles (500 mL) and b) 738 bottles (4 L)
Microbial contamination of Non-Sterile Product;  product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
M&P Food Productions brand Vareniki - farmer cheese, Hand made, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 0716 302618 1
M&P Food Productions brand Vareniki Sour Cherry, Net Wt. 14oz (396g), Keep Frozen, UPC: 7 07163 02615 0
Product contains undeclared wheat and Red #40.
M&P Food Productions brand Vareniki, Potato and Mushroom, Net Wt. 14 oz. (396 g), Keep Frozen, UPC:  7 07163 02617 4
M&P Food Productions brand Hand Made Russian Style Blintzes, (6 pieces): Cheese and Cherry, Net Wt. 14 oz. (396g), UPC Codes: 7 07163 30327 5, Keep Frozen
Product contains undeclared wheat and undeclared FD&C Red #40.
M&P Food Productions brand Vareniki Potato and Onion, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 0 7163 02616 7
M&P Food Productions brand Vareniki Cabbage, Net WT 14 oz. (396g), Keep Frozen, UPC: 7 07163 02619 8
M&P Food Productions brand Hand Made Russian Style Blintzes, (6 pieces): Cheese, Net Wt. 14 oz. (396 g); UPC Codes: 7 07163 30325 1, Keep Frozen
Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Worldwide Distribution - USA Distribution
Surgical punch; sealed pouches  packed in punch shelf box    Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.
Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.
3m Center 2510 Conway Ave , B# 275-5-W-6
Worldwide distribution including US nationwide, including Puerto Rico. Singapore, Australia, Canada, Chile, Colombia, Costa Rica, Brazil, Dominica, Ecuador, Guatemala, UAE, Israel, Japan, Korea, Mexico, new Zealand, Paraguay, Peru, Taiwan, Uruguay, India, Bolivia, El Salvador, Saudi Arabia, and Thailand.
Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to properly charge. In rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy.
Gravy Train With Beef Chunks; packaged in metal cans with Net WT 22 OZ and UPC: 7910051647 on flat case and 7910051647 on cans; or with Net WT 13.5 OZ and UPC: 7910052457 on flat case and 79100034417 on cans; and Gravy Train Chunks In Gravy With Beef Chunks; packaged in metal cans with Net WT 13.2 OZ; UPC: 7910052879 on flat case and 7910034417 on cans; Distributed by: Big Heart Pet Brands, San Francisco, CA 94111;
A TV station notified the firm and stated that certain varieties of their canned pet food products may contain Pentobarbital in low levels.  The firm performed a safety assessment and concluded that no threat to pet safety was present. The firm agreed to conduct a product withdrawal, but the FDA considered this to be a recall once data indicated that the tallow was contaminated with pentobarbital.
Best By range 10 25 19 thru  02 09 2021;   Code range: 6299 through 8040, each with the suffix plant number 803
Kibbles 'n Bits 12 Can Variety Pack; containing 4 cans of Chef's Choice Bistro, Hearty Cuts with Real Beef, Chicken & Vegetables In Gravy; 4 cans of Chef's Choice Homestyle, Meatballs & Pasta Dinner with Real Beef in Tomato Sauce; and 4 cans of Chef's Choice Bistro, Bistro Tender Cuts With Real Turkey, Bacon & Vegetables in Gravy; packaged in metal cans with 12 - 13.2 OZ Cans per case; Total Net Wt 9 LB 14 OZ; Variety Pack paper box UPC: 7910027750; Distr By: Big Heart Pet Brands, San Francisco, CA 94111.     These packages are not meant for individual can sales and are sold as a 12 can Variety Pack.
Code range: 6299 through 8040, each with the suffix plant number 803;   Best By range 10 25 19 thru  02 09 2021;
Ol' Roy Dog Food Strips in Gravy With Turkey & Bacon; packaged in metal cans with Net Wt 13.2 OZ; UPC: 7910017570 on flat case and 8113117570 on cans; Distributed by: Wal-Mart Stores, Bentonville, AR 72712
Skippy Premium Chunks in gravy; Chunky Stew; packaged in metal cans with Net Wt. 13.2 OZ; UPC: 7910052469 on flat case and 7910050249 on cans; Distr. by: Big Heart Pet Brands, San Francisco CA 94111
Kibbles 'n Bits brand Dog Food; Chef's Choice Homestyle Tender Slices With Real Beef, Chicken & Vegetables in Gravy; packaged in metal cans with Net Wt. 13.2 OZ; UPC: 7910052489A on flat case and 7910010380 on cans; Distr. by: Big Heart Pet Brands, San Francisco CA 94111
Code range: 6299 through 8040, each with the suffix plant number 803;  Best By range 10 25 19 thru  02 09 2021;
Gravy Train With Chicken Chunks; packaged in metal cans; Net WT 22 OZ with UPC: 7910051645 on flat case and 7910051645 on cans; and Net WT 13.2 OZ with UPC: 7910052458 on flat case and 7910034418 on cans; Distributed by: Big Heart Pet Brands, San Francisco, CA 94111
Kibbles 'n Bits 12 Can Variety Pack; Chef's Choice Bistro, containing 4 cans of Hearty Cuts with Real Beef, Chicken & Vegetables In Gravy; Chef's Choice Homestyle, 4 cans of Meatballs & Pasta Dinner with Real Beef in Tomato Sauce; Chef's Choice Bistro, and 4 cans of Bistro Tender Cuts With Real Turkey, Bacon & Vegetables in Gravy; packaged in metal cans with 12 - 13.2 OZ Cans per case; Total Net Wt 9 LB 14 OZ; Variety Pack paper box UPC: 7910027750; Distr By: Big Heart Pet Brands, San Francisco, CA 94111.     These packages are not meant for individual can sales and are sold as a 12 can Variety Pack.
Kibbles 'n Bits 12 Can Variety Pack; containing 6 cans of Chef's Choice American Grill, Burger Dinner With Real Bacon & Cheese Bits In Gravy; and 6 cans of Chef's Choice Bistro, Tender Cuts With Real Turkey, Bacon & Vegetables In Gravy; packages in metal cans with 12 - 13.2 OZ cans per case; Total Net Wt 9 LB 14 OZ; Variety Pack paper box UPC: 7910027685; Distr By: Big Heart Pet Brands, San Francisco, CA 94111.    These packages are not meant for individual can sales and are sold as a 12 can Variety Pack.
Gravy Train With Lamb & Rice Chunks, packaged in metal cans with Net WT 13.2 OZ; UPC: 7910005430 on flat case and 7910052543 on cans; Distributed by: Big Heart Pet Brands, San Francisco, CA 94111
Skippy Premium Chunks in gravy; With Beef; packaged in metal cans with Net Wt. 13.2 OZ; UPC: 7910052508 on flat case and 7910050250 on cans; Distr. by: Big Heart Pet Brands, San Francisco CA 94111
Kibbles 'n Bits brand Dog Food; Chef's Choice Bistro Tender Cuts With Real Beef & Vegetables In Gravy; packaged in metal cans with Net Wt. 13.2 OZ; UPC: 7910052486A on flat case and 7910010375 on cans; Distr. by: Big Heart Pet Brands, San Francisco CA 94111
Skippy Premium Strips in Gravy; With Beef; packaged in metal cans with Net Wt. 13.2 OZ; UPC: 7910052509 on flat case and 7910050245 on cans; Distr. by: Big Heart Pet Brands, San Francisco CA 94111
Gravy Train; With T-Bone Flavor Chunks; packaged in metal cans with Net WT 13.2 OZ; UPC: 7910005410 on flat case and 7910052541 on cans; Distributed by: Big Heart Pet Brands, San Francisco, CA 94111
Gravy Train With Strips In Gravy; packaged in metal cans with Net WT 13.2 OZ; UPC: 7910005420 on flat case and 7910052542 on cans; Distributed by: Big Heart Pet Brands, San Francisco, CA 94111
Kibbles 'n Bits brand Dog Food; Chef's Choice Bistro Tender Cuts With Real Turkey, Bacon & Vegetables; packages in metal cans with Net Wt. 13.2 OZ; UPC: 7910052488A on flat case and 7910010378 on cans; Distr. by: Big Heart Pet Brands, San Francisco CA 94111
ProLite Mesh - mesh, surgical, polymeric    ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298.   ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.
Product Code/REF 1010306-06  Lot Number/LOT: 412298
Sezam Kale Salad ingredient kits, net wt. 6.43 pound.  Ingredients are packaged individually and then placed in one large bag.  The ingredients from the kit was mixed and sold in deli cases at retail stores.  The product sold in deli cases has the UPC 2 11565 20216 1.
Sezam Kale Salad kits, 6.43 lbs, are recalled due to undeclared egg.  The wrong dressing packet was added to the Sezam Kale Salad kit and the dressing contains undeclared egg.
Production code 02-14-18 (sell by date of 02-21-18)  Production code 02-15-18 (sell by date of 02-22-18)
Distributed nationwide to States: NY, CT, NJ, MN, VT, NH, MA, PA, OH, VA, MD, WV, KY, DC, FL, MT, ID, WY, UT, CO, KS, NM, HI, AZ, NV, ND, SD, MN, WI, MI, IN, IL, IA, MS, NB    No foreign or govt/VA/military consignees.
Seggiano Artichoke & Garlic Sauce & Spread Net Weight 200g, 7.1 oz, packaged in Glass jar, UPC Code: 812603020381
The Tuscan Kale Pesto was mislabeled as Seggiano Artichoke & Garlic Sauce & Spread and therefore, contains undeclared cashews.
Batch/LOT:  326 - 17/3  Best by date: 05/2019
Cosmic Crunch Granola is recalled due to undeclared coconut flakes.
Freeze-Dried Beef Nibblets packaged under the following band names:   Trudog Crunchy Beef Delight, Freeze-Dried Raw Super Treats for Dogs.  Net Wt. 2.5 oz (71g).  UPC 52990-00522  Trupet LLC, 100 Techne Center Drive, Suite 210, Milford, Ohio 45150.
Pet food has the potential to be contaminated with Salmonella.
Lot 13753, Expiration 5/15/19 (written as 20190514 13753 on label)
Freeze-Dried Beef Nibblets packaged under the following band names:  Vital Essentials, Net Wt. 1 lb. (452g) UPC  33211-00894, Product # 3894.  Carnivore Meat Company LLC, PO Box 9227, Green Bay, WI  54308.
Worldwide Distribution - US Distribution to the states of : GA, IL, IN, PA, SC, TX, UT, VA.   and to the countries of :  Austria, Australia, Bangladesh, Belgium, France, Switzerland, Czech Republic, Germany, Denmark, Spain, United Arab Emirates, United Kingdom, Ireland, Italy, Kuwait, Lithuania, Poland, Portugal, Romania, Sweden, Slovenia, Thailand, Turkey.
Camera System, Television, Surgical without audio    Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.
Wireless Receiver is above the normative accepted limits, in which the radiated emission may interact with other devices in the operating room and cause them not to function properly.
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA  92614, Catalog # R5200-01, NDC 0264-2201-00.
Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.