BREAM - DRY EVISCERATED SALTED FISH, 5.29 oz. (150g), UPC 4606495001346 ---  Product is vacuum packed and consists of salted dry bream fish.
The processed fish product was found to be uneviscerated  based on FDA sampling and analysis.
VOBLA - DRY EVISCERATED SALTED FISH, 5.29 oz. (150 g), UPC 4606495-001308 --- Product is vacuum packed and consists of salted dry caspian roach fish.
The processed fish product was found to be uneviscerated based on FDA inspectional findings.
Recalled product was distributed to the following US states: AL, AZ, CA, GA, IA, IL, FL, KY, MA, MI, MN, MO, OH, OK, PA, TN, TX, UT, and WI. Recalled product was also sent to Canada.
GMO Free Cookie Dough 03-377, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438
Product potentially contaminated with Listeria monocytogenes
Cold Stone Creamery RTE Cookie Dough Puck 2505, NET WT. 22.5 lb (10.215 kg), Aspen Hills, Inc.
Chocolate Chip Cookie Dough in the following packaging configurations    1) Item 03-3003 NET WT. 30 lb (13.61 kg), Aspen Hills, Inc. Garner, IA 50438;  2)  03-300 NET WT. 10 lb (4.54 kg), Aspen Hills, Inc. Garner, IA 50438;  3) 03-300 NET WT. 10 lb (4.54 kg),
Cookie Dough - Chocolate Chip - No Egg  03-307 NET WT. 30 lb (13.61 kg), Aspen Hills, Inc. Garner, IA 50438
Brownie Dough 04-371, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438
Pink Sugar Cookie Dough 05-599, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438
Chocolate Chip Cookie Dough  03-301 NET WT. 30 lb (13.61 kg), Aspen Hills, Inc. Garner, IA 50438
Blue Sugar Cookie Dough 05-598, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438
Snickerdoodle Cookie Dough 1041197 NET WT. 30 lb (13.61 kg), Aspen Hills, Inc. Garner, IA 50438
Cinnamon Bun Cookie Dough 05-3718 NET WT. 30 lb (13.61 kg), Aspen Hills, Inc. Garner, IA 50438
Chocolate Chip Cookie Dough 03-3012 NET WT. 25 lb (11.36 kg), Aspen Hills, Inc. Garner, IA 50438
GMO Free Brownie Dough 04-377, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438
Green Sugar Cookie Dough 05-597, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438
Peanut Butter Cookie Dough Item 06-371, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438
Cookie Dough Pieces Chocolate Chip 10004490 NET WT. 30 lb (13.61 kg), Aspen Hills, Inc. Garner, IA 50438
NO EGG CHOCOLATE CHIP COOKIE DOUGH 03-3014, Net Weight 30 lb (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438
Chocolate Chip Cookie Dough Supplier Number: CS03-105 NET WT. 25 lb (11.3 kg), Aspen Hills, Inc. Garner, IA 50438
Cold Stone Creamery RTE Sugar Cookie Dough Puck 2006, NET WT. 22.5 lbs (10.206 Kg)
Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221.    The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural
During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
All products manufactured or serviced in the time period October 2011 through June 2015.
Product was shipped to the following states: AL. AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY.    Product was also sent to the following countries: CANADA, GERMANY, HONG KONG, ITALY, JAPAN & NEW ZEALAND.
Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
PREMIER EHEC Product Code 608096: Lot # 608096H219, Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.138 Exp Date 9/30/2017; Lot # 608096H222, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.14 Exp Date 1/12/2018; Lot # 608096H224, Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.141 Exp Date 1/29/2018; Lot # 608096H225, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.142, Exp Date 2/5/2018 & Lot # 608096H226, Exp Date 3/6/2018, Detection Antibody Reagent, Lot # 8603.143, Exp Date 3/22/2018.    PREMIER EHEC Bulk Product Code 608096BU: Lot # 608096H220 Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.138, Exp Date 9/30/2017;  Lot #, 608096H223, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.14, Exp Date 1/12/2018 & Lot # 608096H227, Exp Date 3/6/2018, Detection Antibody Reagent, Lot # 8603.143, Exp Date 3/22/2018.
Town and Country Compounding and Consultation Services, LLC
HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459
Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
Risendronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA  19454.
Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH.    No foreign distribution.
Halo One 5F Introducer Sheath 10 cm 5 pack  Product Code: HAL510F    Product Usage:  The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.
Complaints of sheath separation, kinking, and/or tip damage during use.
Halo One 5F Introducer Sheath 90 cm  Product Code: HAL590      Product Usage:  The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.
Halo One 5F Introducer Sheath 45 cm  Product Code: HAL545  The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in cerebrovascular nor the coronary vasculature
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Worldwide Distribution - US Nationwide in the states of: CA, VA, GA, PA, NJ, KY, NY, AR, NM, NC, AL, GA, MI, and the countries of Canada, China, Australia, Israel, Ireland, UK, Germany, Belgium, Italy, France, Czech republic, Spain, Portugal.
Optilite Analyser, Product Code: IE700    Product Usage:  The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma.
Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Opelle Bakery Rainbow Bagel (B-110), case of 96 (4 oz.), Frozen Raw.
53 cases still within shelf-life at initiation of recall
The Rainbow Bagel flavor label lacks declaration of Yellow 5, Yellow 6, Blue 1, Red 40 and Red 3 on its label.
Opelle Bakery Egg Bagel (C-105), case of 60 (3.5 oz.), Frozen Raw.
9 cases still within shelf-life at initiation of recall
The Egg Bagel flavor lacks declaration of Yellow 5 on its label.
Opelle Bakery Egg Bagel (B-105), case of 96 (4 oz.), Frozen Raw.
101 cases still within shelf-life at initiation of recall
Cappuccino Supreme Chai Latte Net Wt. 2 lbs   American Instants, Inc. Flanders, NJ 07836
America Instant Inc. is recalling various chai tea products due to buttermilk and milk products that may be contaminated with Salmonella and were provided by another supplier.
Cappuccino Supreme Gourmet Chai Net Wt. 2 lbs   American Instants, Inc. Flanders, NJ 07836
Lot Number: H084117;  Lot Number: H280074
Cappuccino Supreme Spice Chai Net Wt. 2 lbs   American Instants, Inc. Flanders, NJ 07836
Cappuccino Supreme Spicy Chai Net Wt. 2 lbs   American Instants, Inc. Flanders, NJ 07836
Shelled Pistachios 7.3 oz. packaged in a clear plastic tub, Central Market Shelled Pistachios 7.3 oz. packaged in a clear plastic tub, SunRidge Farms Pistachio Nuts Bulk PLU# 70289
Potential to be contaminated with Salmonella
UPC: 191200005, 198300006, 2702890000; Central Market and the Shelled Pistachios have a shelf life of 90 days and a Best by 1/1/17.  SunRidge Farms pistachio nuts have a 12 month shelf life.
Healthy Living Fireside Roasted Nut Butter packaged in a clear plastic tub
SunRidge Farms Dark Chocolate Pistachios Bulk PLU# 70289 and retail units packaged in clear plastic tub.
SunRidge Farms Women's Vitality Mix Bulk PLU#70610 and retail units packaged in a clear plastic tub.
Merge Cardio software.      Product Usage:  Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
188 sites potentially have the effected versions
If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis.
Great Northern Bakehouse Inc. dba Le Petit Outre
Birdman Bread, each loaf has net wt. 24 oz and 32 oz.. The UPC code ia 6 36428 10200 4.
Birdman Bread is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans.
Sourdough Deli Loaf, each loaf has a net wt. 28 oz.. The UPC is code 6 36428 50200 2
Sourdough Deli Loaf is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans.
Daily Wheat Bread, each loaf has a net wt. 24 oz.. The UPC is  code and 6 36428 50500 3.
Daily Wheat Bread is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans.
Italian Deli Loaf, each loaf has a net wt. 32 oz.. The UPC is  code 6 36428 50200 2.
Italian Deli Loaf is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans.
Whole Wheat Bread, each loaf has a net wt. 32 oz.. The UPC is code 6 36428 50200 2.
Whole Wheat Bread is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans.
Brewers Grain Deli Loaf, each loaf has a net wt. 24 oz.. The UPC code is 6 36428 10300 1.
Brewers Grain Deli Loaf is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans.
NY Rye Deli Loaf, each loaf has a net wt. 32 oz.. No UPC as this is for food service only.
NY Rye Deli Loaf is recalled due to undeclared soy lecithin. The soy allergen is present in DDA pan spray (release agent) and the firm used it to spray the loaf pans.
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only.     Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.
Lack of 510k clearance for design modification.
Model No. 66800164; All pumps of this model are affected.
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only.     Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.
Model No. 66800161 when sold separately, Model No. 66800164 when sold with RENASYS GO NPWT Pump; Serial No. < than 144500875.
California, Texas and Colorado. No foreign/VA/govt/military
Dark Chocolate Dolcini, In clear plastic cup, 72 individual servings, Store frozen
Dark Chocolate Dolcini and Limoncello Dolcini were made using ingredients which was allegedly affected by the dry milk recall from Valley Milk and could potentially be contaminated with Salmonella.
Limoncello Dolcini , In clear plastic cup, 72 individual servings, Store frozen
USA (nationwide) and Internationally to ARGENTINA
Active Articulation ArComXL Polyethylene Bearings  Active Articulation ArComXL Bearings item XL-200152
Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging.  Risk of delay in surgery.
RingLoc ArComXL Highly Crosslinked Polyethylene Liners  ArComXL High Wall +3mm Liners Size 23 item XL-108323  ArComXL MaxRom +3mm Liners Size 23 item XL-108223
Pineapple Nut Delight NET WT. 12 oz. DISTRIBUTED BY: BROOKSHIRES TYLER, TX 75701 UPC: 0 96938 90008 6
Texas Kitchen Salads Tropical Fruit Supreme KEEP REFRIGERATED Nutrition Facts NET WT. 16 oz. in plastic containers, Packed By: Ron's Home Style Foods, Inc. Houston, TX 77021 UPC: 0 96938 84101 3
Texas Kitchen Salads Pistachio Cream KEEP REFRIGERATED Nutrition Facts NET WT. 16 oz. in plastic containers Packed By: Ron's Home Style Foods, Inc. Houston, TX 77021 UPC: 0 96938 83101 4; Pistachio Cream NET WT. 12 oz. DISTRIBUTED BY: BROOKSHIRES TYLER, TX 75701 UPC: 0 96938 90007 9
LIZARD FISH (Eviscerated), 15 KGS, PRODUCT OF VIETNAM --- DISTRIBUTED BY ARCADIA TRADING INC. BROOKLYN, NY 11211
The imported Lizard Fish was found to be uneviscerated based on FDA  sampling and analysis.
Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.
Subpotent Drug: out of specification results for assay test.
AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
APD Set with Cassette 3-Prong Peritoneal Dialysis Set    Indicated for use in the treatment of patients  with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.
Customer complaints received for the presence of leaks
AZ, CA, CO, FL, HI, IA, ID, IL, KS, MN, NC, NJ, NY, PA, OH, OR, RI, TX, UT, VA, WA and WI
Poppies Belgian Eclairs,Net Wt. 710 g/25 oz., Contents 50 ct. Mini Eclairs, UPC Code:  0 08563 10710 5.
Product contains milk product from a supplier that is recalling product due to the possible presence of Salmonella.
Boston Sundae Cake - Freezer and Boston Sundae Cake Chocolate and Boston Sundae Cake packaged on plastic trays with domed lids.
Product has potential to be contaminated with Salmonella.
Boston with Fresh Fruit packaged on plastic trays with domed lids.
Boston Choc/Fudge Iced packaged on plastic trays with domed lids.
Fresh Strawberry Boston - FRZ and Fresh Strawberry Boston Cake packaged on plastic trays with domed lids.
Holiday Chocolate Fudge Boston Spider packaged on plastic trays with domed lids.
Un-iced 8 inch Boston Cream Cake packaged in domed trays then put in brown corrugated cases.
Worldwide distribution.   US Nationwide; BioMerieux Subsidiaries in: Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech republic, Germany, Spain, France United Kingdom, Greece, China, Hungary, India, Italy, Japan, South Korea, Netherlands, Poland, Portugal, Russia Fed., Sweden, Singapore, Thailand, Turkey, South Africa; Distributors in: Peru, Kenya, Morocco, Serbia, Romania, Uruguay, Latvia, Dutch Antilles, Israel, Georgia, Armenia, Malaysia, Belarus and Direct Customers in: Togo, Djibouti, Burkina Faso, Mongolia, Zimbabwe, Uganda and Iraq.
A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil).   This is the same issue as in recall Z-2342-2016.
Reference number: 200293, Lot number: 16072701.
A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil).  This is the same issue as in recall Z-2342-2016.
Reference number: 280133, Lot numbers: Z017KA1MS, Z017KB1MS, Z017LE1MS,  Z017MA1MS, Z017NA1MS, Z017NB1MS, Z017NC1MS and Z017ND1MS.
Dried Smoke Chipotle Flavored Kettle Cooked Potato Chips  2.0 oz.
Herrs Foods is announcing a product recall on Chipotle flavored Kettle Potato Chips under the Herrs and the Peddlers Pantry Brand, 2.0 oz.  due to possible health risk. These products were flavored with Chipotle seasoning that contained a milk ingredient . The milk ingredient is being recalled due to a potential risk of Salmonella contamination.
Smoked Chipotle Flavored Kettle Cooked Potato Chips  2.625 oz and 8.0 oz
Herrs Foods is announcing a product recall on Chipotle flavored Kettle Potato Chips under the Herrs and the Peddlers Pantry Brand, 2.625 oz., and 8.0 oz. due to possible health risk. These products were flavored with Chipotle seasoning that contained a milk ingredient. The milk ingredient is being recalled due to a potential risk of Salmonella contamination.
Distributed within South Central Pennsylvania
Dieffenbach's Sour Cream and Onion Kettle Chips 9 oz. and 2 oz. bags
Womelsdorf, PA - Dieffenbach's Potato Chips, Inc. is issuing a voluntary recall for our Sour Cream & Onion Kettle Chips due to information they received from their seasoning supplier that an ingredient in the seasoning may contain traces of Salmonella.
Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland.
Medacta International SA, M.U.S.T. Rod, REF 03.50.403, Size 5.5mm, Length 480mm, Type Straight, Mat Ti 6-Al 4-V    The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.
Damaged packaging, lack of sterility assurance
Fresenius Medical Care Renal Therapies Group, LLC
Nationwide  Foreign: Canada,  Mexico, Jamaica, Germany, Guam
Fresenius 2008K2 Series : Hemodialysis System
Fresenius 2008T Series Hemodialysis System
Fresenius 2008K@home Series : Hemodialysis System
Fresenius 2008K Series : Hemodialysis System
Worldwide Distribution - US (Nationwide) - Internationally to Belgium, Switzerland, Germany, Italy, South Korea, Netherlands, and Japan.
143 packs of 100 tips; 104 packs of 20 tips
Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe.
Lot Numbers: BD6KM, BCVPG, BCTBY, BD3K4, BCWVZ
ENCHILADA SEASONING    NET WEIGHT: 50. 00  LBS
Milk Ingredient that was recalled went into  Chesapeake Spice products.
TR-MEXICALI SAUCE SEASONING  NET WEIGHT: 50.00 LBS
GREEN BEAN SAUCE SEASONING  NET WEIGHT: 50.00 LBS
U.S. distribution to the following; MA, GA, NY, IA, CA, IL, UT, NJ, NC, MD, MN.    Foreign distribution to the following; UK, Germany, Spain, France.
Digital RID Plate Reader and Software    Product Code: AD400
If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.
U.S. distribution to the following; AR, PA, GA, NC, KY, VA, CA.    Foreign distribution to the following; Uk, Germany, France, Italy, Spain, Czech Republic, Portugal, Belgium.
Optilite Freelite Lambda Free Kit  Product Code: LK018.OPT, LK018.OPT.A    Protein testing kit.
Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.
U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ.    Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.
Human Lambda Free SPAPlus Kit    Product Code: LK018.S    Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
Calibration curve activity has increased over time in the kit lots listed.
Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
Freelite Human Lambda Free Kit for use on SPAPLUS    Product Code: LK018.S, LK018.10S  Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
A change in the calibration curve causing an increase in false prozone flags.
AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550.    AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving process. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.
Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.
One distributor - Lancaster Foods, Jessup, Maryland
Fresh Express Hearts of Romaine salad, 9 oz., clear/labeled salad bag/ 6 bags per case
Undeclared allergens (milk, wheat, fish (anchovy) and egg.
Lot # H34711A and H34711B  product of USA
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed by Perrigo, Allegan, MI --- NDC 45802-736-84, UPC 345802736840
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Worldwide Distribution - US Distribution and to the countries of :  Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey and United Kingdom.
AFX Endovascular AAA System, Endoleak Type IIIA
Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).
The correction is not lot specific. It applies to AFX procedures conducted after June 2013
Great Basin Staph lD/R Blood Culture Panel    The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.
32 Kits (320 individual disposable cartridges)
The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.
Lot 1629103  Catalog Number: GBSIDR-10  Unique Device ldentifier (UDl): B1 78GBS|DR102
Walnut Chocolate Chunk Cookies, Hungry Heart brand, packaged in a clear Cello bags, heat sealed. 6 units per bag. Net wt. 9.75 oz. (276g)
Walnut Chocolate Chunk Cookies are recalled due to undeclared wheat and soy (from the pan release agent spray)
Cracker Jax, Hungry Heart brand, packaged in a clear Cello bag, heat sealed. Net wt. 8 oz. (227g).
Cracker Jax are recalled because butter is declared, but milk is not declared, and soy (from the pan release agent spray) is not declared
Chocolate Chip Sea Salt Cookies, Hungry Heart brand.  Product is packaged in a clear cello bags, heat sealed. 1 unit per bag. Net wt. 2.75 oz. (78g).
Chocolate Chip Sea Salt Cookies are recalled due to undeclared wheat and soy (from the pan release agent spray)
Peanut Butter Cookies, Hungry Heart brand. Product is packaged in a clear Cello bag, heat sealed. 6 units per bag. Net wt. 6.5 oz. (184g)
Peanut Butter Cookies are recalled due to undeclared soy (from the pan release agent spray)
Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
AFX Endovascular AAA System, Endoleak Type IIIA    Common Name: AFX Bifurcated and Accessory Stent Grafts  Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment    The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
The correction is not lot specific. It applies to AFX procedures conducted after July 2015
US, and worldwide:    Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
AFX Endovascular AAA System, Endoleak Type IIIB    Common Name: AFX Bifurcated and Accessory Stent Grafts  Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular  AAA System (AFX System).
US and worldwide:     Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
AFX Endovascular AAA System, Endoleak Type IIIB;  The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
AFX Endovascular AAA System, Endoleak Type IIIA    Product Usage:  The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
The correction is not lot specific. It applies to AFX procedures conducted after October 2015
AFX Endovascular AAA System, Endoleak Type: IIIB    Common Name: AFX Bifurcated and Accessory Stent Grafts  Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment    The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
WOOD FARMS Ranch dressing, EX418, NET WT: 6.4 oz, UPC 9172850097
Spice blends were manufactured using dried buttermilk which was subsequently recalled due to positive Salmonella results on environmental sampling.
Tupperware, Southwest Chipotle Seasoning, Assaisonnement Chipotle du sud-ouest, NET WT. 2.0 OZ. (56g)
U.S. distribution to the following, CA, NM, HI, OR, AZ.    No foreign distirbution.
Manufacture date code: 160526  Manufacture date code: 180526    Lot#:  160526013600Y0027032
U.S. distribution to the following; CA.    No foreign distribution.
Signature Kitchens Tuna Solid White  12 oz.    UPC Codes: 2113035611
Signature Kitchens Tuna Chunk Light  20 oz. (4 pack), 12 oz., 5 oz.    UPC Codes: 2113033549, 2113035609, 2113035612
Multiple U.S. States including Puerto Rico and worldwide (Australia, Brazil, Canada, China, Chile, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Poland, Republic of Panama, Singapore, Spain, Venezuela)
Ortho reagent products, not meeting product specifications, were distributed.
Starkey Spring Water, 16.9 FL oz. (500 mL) glass bottle. packed 15 bottles in cardboard box.  Product UPC 8 11904 02000 7.       Case UPC 8 11904 02002 1.
12  ppb of arsenic was detected in water sample
Assorted Croissant:: sold in 4 pack clamshell package.  Ingredients: Plain Croissant: ( dough [enriched unbleached flour (wheat flour, malted barley flour, niacin, iron, thiamin, mononitrate, riboflavin, folic acid) water, butter, sugar, milk, yeast, salt, ascorbic acid, enzymes} topping : Egg spray.  Chocolate Croissant: ( dough [enriched unbleached flour (wheat flour, malted barley flour, niacin, iron, thiamin, mononitrate, riboflavin, folic acid) water, butter, sugar, milk, yeast, salt, ascorbic acid, enzymes}. Filling [chocolate bar (sugar, chocolate liquor, cocoa butter, soya lecithin, whole milk powder, natural vanilla extract)]. Topping egg spray:  Almond Croissant:  Dough ( water, wheat flour, sugar, milk [powder fat whole], salt, yeast, ascorbic acid, butter.  Filling: Almond paste, butter, sugar, eggs. Topping (apricot glaze, almonds. Contains Milk, Eggs, Tree Nuts, Wheat, Soy.    Note: This information is from the new label.    Manufactured by Bakers of Paris, Brisbane, CA for Whole Foods Markets.    UPC: Croissant Assorted 4 Pack Baker Paris, 241598007990
Labeling for Croissants sold in Northern CA fails to declare  egg in the ingredients list or allergen information. The croissants are manufactured with an egg wash.
Packed on dates of 1/4/17 or earlier and sell by dates of 1/7/17 or earlier
Almond Croissant:: sold in self serve cases and 4 pack clamshell package.  Ingredients: Dough ( water, wheat flour, sugar, milk [powder fat whole], salt, yeast, ascorbic acid, butter.  Filling: Almond paste, butter, sugar, eggs. Topping (apricot glaze, almonds. Contains Milk, Eggs, Tree Nuts, Wheat.     Note: This information is from the new label.    Manufactured by Bakers of Paris, Brisbane, CA for Whole Foods Markets.    UPC: Croissant 4 Pack Baker Paris, 241593007994;             Self Serve case Almond Croissant, 46000058559
Chocolate Croissant:: sold in self serve cases and 4 pack clamshell package.  Ingredients: Dough (enriched unbleached flour [wheat flour, malted barley flour, niacin, iron, thiamin, mononitrate, riboflavin, folic acid] water, butter, sugar, milk, yeast, salt, ascorbic acid, enzymes.  Filling: Chocolate bar [sugar, chocolate liquor, cocoa, butter, soya lecithin, whole milk powder, natural vanilla extract. Topping (egg spray). Contains Milk, Eggs, Wheat, soy.    Note: This information is from the new label.    Manufactured by Bakers of Paris, Brisbane, CA for Whole Foods Markets.    UPC: Croissant 4 Pack Baker Paris, 241593007993;             Self Serve case Chocolate Croissant, 46000058528
Croissant:: sold in self serve cases and 4 pack clamshell package.  Ingredients: Dough (enriched unbleached flour [wheat flour, malted barley flour, niacin, iron, thiamin, mononitrate, riboflavin, folic acid] water, butter, sugar, milk, yeast, salt, ascorbic acid, enzymes. Topping (egg spray). Contains Milk, Eggs, Wheat. This information is from the new label.    Manufactured by Bakers of Paris, Brisbane, CA for Whole Foods Markets.    UPC: Croissant 4 Pack Baker Paris, 241593 007995;             Self Serve case Croissant, 46000058529
U.S. distribution to the following; TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, PR, IL, OH, NY, MD, NJ, MN, MI, CT, VA, GA, UT, KS, WA, MI, HI.    Foreign distribution to the following; Canada, Spain, Israel, Singapore, Kosovo, Austria, Brazil, Malaysia, Australia.
Ambra PACS    UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R  Software Version Number: V3.16.13.0    Intended for use as a primary diagnostic and analysis tool for diagnostic images.
A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.
AZ, AR, CA, CO, CL, GA. IL, IN, LA, MA, MI, MN, MO, NV, NH, NJ,  NY, NC, OH, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bangladesh, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Laos, Lithuania, Malaysia,  Malta, Mexico,  Morocco, Myanmar, Napal, Namibia, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Peru, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam, Zimbabwe
Monaco RTP System.    Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Incorrect dose after editing beam number an wedge angle.
Worldwide Distribution - US including SC, GA, TX, OH, IA, NY and foreign distribution to Switzerland and Malaysia
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System  Diagnostic ultrasound imaging or fluid flow analysis of the human body
Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit is not displayed, i.e., centimeters or millimeters.  As such, the user expects that the measurement is taken calculated in centimeters, consistent with other values in the report.  In actuality, the measurement is taken in millimeters.  When this updated measurement is used in an average calculation, the result appears incorrect as two measurements are interpreted as centimeters while the user corrected value is interpreted as millimeters.  If the user selects a Calc Result display as Min or Max, the values are also interpreted as millimeters when centimeters were expected.
Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654
Subpotent Drug: Out of specification result for pramoxine hydrochloride
The distribution is specifically in the United States (VA, IL, MD, IN, WI, MI, NJ)
FPI Breaded Round Shrimp Tail-On 1001990,   12-8 oz. cartons per master case,   Master case 6 lbs. (2.72 kg)
Product contains undeclared milk and eggs
Lot Numbers being recalled:  0046351131 and 0046351230
Worldwide Distribution - US (nationwide)and Internationally to Austria, Belgium, France, Germany, Greece, Italy, Ireland, Monaco, Poland Portugal, Romania, Spain, Sweden, Turkey, Israel, Argentina, Florida, Mexico, Chile, Brazil, Japan, Singapore, Malaysia, and Thailand.
AFX Endovascular AAA System     Item Number	Item Description  F0070305	                     A2525/C75 V  F0070308	                     A2828/C75 V  F0070312	                     A3434/C80 V  f00553	                     I1616/C55F SA  F00556	                     I2013/C70F SA  F00555	                     I2020/C55F SA  F00558	                     IS2025/C55 SA  F00559	                     IS2025/C65 SA  F0072605	                     A2525/C75O20 V  F0072606	                     A2525/C95O20 V  f00552	                      I1616/C88 SA  F00557	                      I2013/C88F SA      The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA
Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance  and treatment.