Product was distributed to retail stores in the Kansas City metro area.
Choc + Chip, Chocolate Chip Cookie and Vanilla Ice Cream Sammich, packaged in 4.5 oz plastic bags. Shatto Milk Company, Osborn, MO.
Undeclared allergens: Butter fails to disclose the presence of milk and ice cream sandwiches fail to disclose the presence of wheat.
All best by dates prior to November 2017
Cookin' Unsalted Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO.
Oatmeal, Oatmeal Raisin Cookie And Caramel Sea Salt, Ice Cream Sammich, packaged in 5 oz plastic bags. Shatto Milk Company, Osborn, MO.
Buzzzz Honey Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO.
Brownie, Chocolate Brownie and Vanilla, Ice Cream Sammich, packaged in 5 oz plastic bags. Shatto Milk Company, Osborn, MO.
Sugary, Sugar Cookie And Strawberry Ice Cream Sammich, packaged in 4 oz plastic bags. Shatto Milk Company, Osborn, MO.
Plain Ol' Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO.
Aromatic Garlic Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO.
Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6145-10
Labeling: Label Mixup; potentially mislabeled
Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031
Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6151-10
Amitriptyline HCL Tablets, USP 50 mg,  100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10
Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987
Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Ultrasound Video Gastroscope, Model EG-3870UTK.    The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.
Ultrasound Video Gastroscope, Model EG-3670URK,     The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
LA, PA, OH, IL, KY, IN, TN, TX, FL, SC, CO, CA, AR, NC, MN, ME, AL, MI, VA, NY, IA, NJ, MA, MS, GA, WI
Broaster Recipe Crinkle Cut Seasoned Wedges / 96698 (5 lb bags)
Battered Jo-Jo Wedges / 00047 (5 lb bags)
Valero Baby Wedges with Crisp Coat UC Coating / 51049 (5 lb bags)
Medium Coated Jo-Jo Wedges / 00040 (5lb bags)
Seasoned/Battered Baby Jo-Jo Wedges / 00049 (5 lb bags)
Extra Large Coated Jo-Jo Wedges / 00048 (5 lb bags)
Sysco X-Large Jo-Jo Wedges / 7641749 (5 lb bags)
Medium Seasoned/Battered Jo-Jo Wedges / 00129 (5 lb bags)
Medium Battered Jo-Jo Wedges / 00126 (5 lb bags)
Extra Large Seasoned/Battered Jo-Jo Wedges / 00148 (5 lb bags)
Worldwide Distribution - US Nationwide in the states of:  AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, MD, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WV.  and the countries of: Italy, Austria, Turkey, United Arab Emirates, Germany, Spain, Saudi Arabia, Switzerland, Japan Kuwait, Denmark, Sweden, United Kingdom, Belgium, France, Australia, Netherlands, Greece, South Korea.
Tissu-Trans Filtron 250, 3-TT-FILTRON 250.  Product Usage:  Intended for fat transfer and liposuction.
Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
Tissu-Trans MEGA 1500, 3-TT-MEGA 1500.    Product Usage:  Intended for fat transfer and liposuction.
Tissu-Trans Filtron 500, 3-TT-FILTRON 500.    Product Usage:  Intended for fat transfer and liposuction.
Tissu-Trans Filtron 100, 3-TT-FILTRON 100.      Product Usage:  Intended for fat transfer and liposuction.
Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000.    Product Usage:  Intended for fat transfer and liposuction.
Tissu-Trans SFILL 360, 3-TT-SFILL 360.    Product Usage:  Intended for fat transfer and liposuction.
Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000.    Product Usage:  Intended for fat transfer and liposuction.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA    The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA    The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
Penrose-St Francis Health Services Blood Bank
Apheresis Platelets, Leukocytes Reduced, Irradiated
Blood product, in which labeling applied to blood unit or product incorrect or missing information, was distributed.
Worldwide Distribution - US (nationwide) and Internationally to Canada.
Medtronic Straight Suction 9733449 EM ENT, reusable, Rx.  The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.  The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Medtronic Curved Suction 90 9733451 EM ENT,  reusable, Rx.  The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.  The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx.  This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction).  The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.  The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory.  The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf.  Therefore, no kit lot number is being provided.To be provided
Medtronic Instrument Set EM ENT, Ref.  #9733452 and #9733452-G02, reusable, RX.  This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451,  90 deg Curved Suction.  The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.  The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory.  The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf.  Therefore, no kit lot number is being provided.
Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx.  The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.  The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX.  This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction).  The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.  The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx.  The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.  The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX.  This kit contains 9734308, Small Straight suction.  The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.  The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
North Carolina; New Jersey; South Carolina
Apheresis Red Blood Cells, Leukocytes Reduced
Blood products, lacking assurance of proper storage and transport temperatures, were distributed.
Platelet products, lacking assurance of proper leukocyte reduction, were distributed.
Product was shipped to the following states: AL, FL, GA, IN, KY, MA, ME, MI, MO, MS, NC, NY, OH, PA, TN, TX & VA.
During an FDA inspection the firm was informed that cans may have defective side seams which may cause the cans to leak or allow for growth of C. botulinum..
Lot Codes 6057S LC and 6057P LC Best By date of Jun 2019
Lot Codes 6077S RR, 6077P RR, 6087S RR, 6087P RR with the Best By date of Jun 2019
During an FDA inspection the firm was informed that cans may have defective side seams which may cause the cans to leak or allow for growth of C. botulinum.
Lot Codes 6097S GF and 6097P GF with Best By date of Jun 2019
Blood product, in which labeling/crossmatch tag, tie tag or transfusion record incorrect or missing information, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
The product was distributed to retail grocery stores in the Minneapolis and St. Paul metro area.
Hy-Vee, Cheese Pizza, 16'' Traditional Crust, UPC 288928 611991, Net Wt. 47 oz (2 lb 15 oz) 2.94 lb (1.332 kg), West Des Moines, IA
Product contains soy lecithin, but soy is not declared on the product's Contains statement and soy lecithin is not declared on the ingredient list
Best if Used by Dates: 04-23-2017 thru 07-26-2017
Hy-Vee, Cheese Pizza, 12'' Thin Crust, UPC 288914 908999, Net Wt. 17 oz (1 lb 1 oz) 1.06 lb (482 g), West Des Moines, IA
Hy-Vee, Cheese Pizza, 12'' Traditional Crust, UPC 288900 908996, Net Wt. 26 oz (1 lb 10 oz) 1.62 lb (737 g), West Des Moines, IA
Hy-Vee, Cheese Pizza, 16'' Thin Crust, UPC 288942 611991, Net Wt. 29 oz (1 lb 13 oz) 1.81 lb (822 g), West Des Moines, IA
Worldwide distribution.  US Nationwide and Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, France, India, Japan, Mexico, Netherlands, Panama, Portugal, Romania, Spain, Thailand, UAE, and United Kingdom
ORA System with VerifEye, Catalog Number 8065998300  For use during intraocular lens surgery
Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coefficients for an IOL model being downloaded from the Alcon server in an incorrect order.
ORA System with VerifEye+ Cart, Catalog Number 8065998307  For use during intraocular lens surgery
Blood products, in which quality control and distribution/testing not performed, incompletely performed, or not documented, were distributed.
Worldwide Distribution - US including AL, AR, AZ, CA,CO, CT, DC, FL,  GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME,  MI, MN,M MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.    Foreign Distribution: India, ANZ, Taiwan, Hong Kong, Canada, China, Japan, Korea, Malaysia, Philippines, Singapore, Thailand, Indonesia, Vietnam, Albania, Algeria, Austria, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Israel, Italy, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, Argentina, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Mexico, Panama, Peru, Puerto Rico, Uruguay, and Venezuela.
Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in DBS lead placement beyond the intended target.
Blood product, manufactured without the entire quantity of additive solution, was distributed.
Product was found to contain the bacteria Pseudomonas aeruginosa at an average level of 108 bacteria per gram of product.
US and Worldwide:    CHINA, THAILAND, Peru, Puerto Rico, ANGOLA, CROATIA, GUINEA, MONTENEGRO, SLOVAKIA, AUSTRALIA, DEM. REP. OF THE CON, HUNGARY, MOZAMBIQUE, SLOVENIA, AUSTRIA, DENMARK, IRELAND, NETHERLANDS SOUTH AFRICA, BELGIUM, El Salvador, ITALY, NEW ZEALAND, SPAIN, BENIN, ESTONIA, JORDAN, NIGER, SWEDEN,,BULGARIA, ETHIOPIA, KENYA, NIGERIA, SWITZERLAND, BURKINA FASO, FINLAND, LATVIA, PARAGUAY, TANZANIA, BURUNDI, FRANCE, LUXEMBOURG, ROMANIA, UGANDA, CAMEROON, GAZA & JERICHO, MALAWI, SENEGAL, UNITED KINGDOM,  CHAD, GERMANY, MALI, SERBIA, ZIMBABWE
Abbott RealTime HIV-1 Amplification Reagent Kit
Abbott RealTime HIV-1 assays, with a potential in certain circumstances to exhibit false results, were distributed.
Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by:  Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85
Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by:  Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47
Rugby  Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, ?Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59
Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by:  Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85
Fairway brand Cookies Blondie, 10 oz.    Item Code 268492 XXXXXX or 263413 XXXXXX.
Nationwide: Iowa, Minnesota, Wisconsin, South Dakota, Illinois, Ohio, New York, Pennsylvania, and California    No foreign/govt/VA/military consignees.
Friendly Farms Key Lime Crunch Tilts Greek Lowfat Yogurt, 5.3oz plastic cup, Best by date: AUG/26/2017 04-161 and SEP/22/2017 04-161, UPC for this product is 041498239091, Keep refrigerated
Recalling Friendly Farms Key Lime Crunch Tilts because it may contain undeclared almond pieces.
Lot# A8872 Best by date 8/26/2017  Lot# A5003 Best by date 9/22/2017
California, Colorado, Minnesota, Missouri, North Carolina, New York, Ohio, Oregon, South Carolina and Canada
Gold Coast Packing Broccoli Florets;    packed in the following configurations:  12 x 2 lb - Product code 508215 - Costco Canada;  1 x 40 lb.- Product code 504405  4 x 3 lb. - Product Codes 503401; 503409  4 x 3 lb. pizza cut -Product Code 503405  4 x 3 lb. - Mini florets - Product code 503412  2 x 5 lb. - Asian cut -Product code 505200;    Distributed by Gold Coast Packing Co., Santa Maria, CA 93454
Firm test results found potential E-coli contamination in Broccoli Florets
Use by Date: 8/12/17;    4 x 3 lb.   1.product code 503401: lot codes: 208 171053;   2. product code 503409; lot code 208 170812;  3. Pizza cut product code 503405; lot code 208 170976;  3. Mini Florets product code 503412, lot code 208 170976.    12 x 2 lb. Costco Canada, product code 508215; lot codes 208-170812, 208 171053.    2 x 5lb.;  Asian cut product code 505200,  lot 208 171053.    1x40 lb.   Product code 504405, Lots 208 170976, 208 170996;
Blood products, collected from a donor who lived in a malarial endemic area, were distributed.
Blood products, lacking assurance of proper temperature monitoring, were distributed.
Red Blood Cells, Leukocytes Reduced, Irradiated
Distributors in 17 states: WI, TN, KY, OH, MI, FL, PA, GA, TX, KS, NE, MN, OK, LA, MO, SD, MS
IQF French Style Green Beans and IQF Cut Green Beans may be contaminated with Listeria monocytogenes.
Product was shipped to the following states: IN, KY, MO & TN.
The Comfy Cow Banana Pudding Y'all Ice Cream 1 pint
The firm is recalling various brands of ice cream due to E. coli & high Coliform Bacteria counts in various products.
The Comfy Cow Double Fold Vanilla Ice Cream 1 pint
The Comfy Cow Strawberry Fields Forever Ice Cream 1 pint
The Comfy Cow Salted Caramel Ice Cream 1 pint
The Comfy Cow Cookies & Cream Ice Cream 1 pint
The Comfy Cow Intense Dark Chocolate Ice Cream 1 pint
The Comfy Cow Georgia Butter Pecan Ice Cream 1 pint
The Comfy Cow Chocolate Squared Ice Cream 1 pint
5 distributers in 4 states: MN, WI, IA, and ND.
Imperial Fresh Veg Blend 7-Way, 2/5#, 7512033
Broccoli has the potential to be contaminated with E. coli O26
Broccoli Florets packaged with the following [Product Brand, amount per case / pounds per package, item code]:  1) Imperial Fresh, 1/5#, 6712509;  2) Imperial Fresh, 1/3#, 9731258;  3) Imperial Fresh, 1/5#, 1515360;  4) SYSCO Imperial, 4/3#, 6540843;  5) Imperial Fresh, 1/5#, 6709356;  6) SYSCO Imperial, 4/3#, 6540843
US Foods VEG MIX BROC/RED-ON-PEP STRIP, 2/5#, 8651259
Mary's Harvest brand,  Stir Fry Asian, 6/18 oz packages, UPC 8 8724179812 1.    Ingredients statements: Green Pepper, Broccoli, Red Pepper, Snow Peas, White Onion, Red Onion, Bok Choy, Carrot, Mushrooms, Baby Corn, Bamboo Shoots, and Water Chestnuts.
Product is recalled due to potential contamination with E.coli O26.
Kroger (QFC and Fred Meyer) brand, VEGETABLE MEDLEY KFK, Net wt.  10 oz, UPC 8 2676618505 4.    Kroger Main & Vine brand, VEGETABLE MEDLEY, Net wt. 10 oz, UPC 8 2676618749 2.    Mary's Harvest brand, Rainbow Veggies,  6/24 oz. packages, UPC 0 9250438263 8.    Mary's Harvest brand, Veggie Medley Bag, 6/20 oz	packages, UPC 0 9250470230 6.    Ingredients: Broccoli, Cauliflower, and Carrots.
834/10 oz. packages; 14 cases (6/24 oz. packages); 19 cases (6/20 oz. packages)
Kroger (QFC and Fred Meyer) brand, Broccoli Floret KFK, Net wt. 8 oz	, UPC 8 2676618506 1.    Kroger Main & Vine brand, Broccoli Floret, Net wt. 8 oz, UPC 8 2676618750 8.    Mary's Harvest brand, Broccoli Buds or Broccoli Florette,  Net wt. 16 oz, UPC 8 8724180456 3.    Mary's Harvest brand, Broccoli Buds Pizza Cut, Net wt. 3 lb. No UPC.    Mary's Harvest brand, Broccoli Buds Pizza Cut, 6/3 lb. packages per case. No UPC.    Mary's Harvest brand,  Broccoli Florette, net wt. 12 oz. UPC 8 8724180789 2.      Ingredients Statement: Broccoli
1089/8 oz. packages; 1 case (6/16 oz packages); 3/3 lb. cases; 27 cases (6/3 lb. packages); 1 case (6/12 oz. packages)
Broccoli  FLORET KFK 8 oz, Use by: 8/5/17-8/8/17.    Broccoli  FLORET 8 oz, Use by: 8/5/17- 8/8/17.    Broccoli Buds or BROCCOLI FLORETTE 6/16 oz, Use by: 8/10/17.    Broccoli  Buds PIZZA CUT 3 lb., Packed on: 8/1/17.    Broccoli  Buds PIZZA CUT 6/3 lb, Packed on: 7/31/17- 8/2/17.    Broccoli Florette  6/12oz, Use by: 8/11/17.
Safeway, Stir Fry Vegetables SW, 4/9.5 oz packages, UPC 8 2676611720 8.    Ingredients statements: Onions, Broccoli, Green Bell Pepper, Carrots, Zucchini Squash, Red Bell Pepper, Snow Peas
Mary's Harvest brand,  STIR FRY MIX LEGACY, Net Wt. 5 lb. No UPC.    Ingredients statements: Red Onion, Red Peppers, Carrot, Broccoli, Green Peppers, and Green Cabbage.
Mary's Harvest, VEGETABLE BLEND NSM, 4/5 lb.	packages, no UPC.
Mary's Harvest,  Veggie Cup,  6/12 oz	pacakges, UPC 0 9250470153 8.  Marys Harvest, Veggie Cup,   6/ 8 oz	packages, UPC 0 9250470021 0.
3 cases (6/12 oz packages); 13 cases (6/8 oz packages)
Fred Mayer /Garden Highway,  VEGETABLE WEEKENDER  Kit,  Net wt.   6.75 lb. No UPC.
Whole Foods Market,  Vegetable Bowl with Hummus, 2/34 oz. packages, UPC 8  26766 82064 1.      This item was exported to Canada.
Mary's Harvest brand, SLD BROCCOLI KIT, net wt. 6 lb. No UPC.    Ingredients statement: Broccoli, Broccoli Slaw Blend, Coleslaw dressing, Red Onion, Raisin, Sun Flower seeds, Bacon Bits.  Contains Egg
Mary's Harvest,  STIR FRY VEGETABLES STORE PACK, net wt. 5 lb. No UPC.     Ingredients statements: Broccoli, Green peppers, Carrot, Red Peppers, Yellow Onion, Red Onion, Yellow Peppers, Snow Peas, Daikon Radish.
Mary's Harvest brand, Vegetable Snack Pack,  6/12 oz packages, UPC 0 9250440001 1.    Mary's Harvest brand, Vegetable Tray, 3/36 oz packages, UPC 0 9250472267 0.     Mary's Harvest brand,  Vegetable Tray Segment, 2/58 oz packages, UPC 0 9250475790 0.    Kroger (QFC and Fred Meyer), Vegetable Party Tray w/ Dip,  Net wt. 2lb 14oz (46 oz.), UPC 8 2676614541 6.    Kroger (QFC and Fred Meyer), Vegetable Tray w/ Dip, Net wt. 4 lb 13.5oz (77.5 oz), UPC 8 2676614542 3.       INGREDIENTS are Cauliflower, Carrot, Celery, Broccoli, and Ranch Dip.
83 cases (6/12 oz. packages); 54 cases (3/36 oz. packages); 4 cases (2/58 oz. packages); 458/46 oz. packages; 132/77.5 oz packages
Mary's Harvest, Stir Fry Vegetables Bowl, 6/1 lb packages, UPC 0 9250438264 5      Ingredients statements: Carrots, Yellow Peppers, Green Peppers, Snow Peas, Red Peppers, Green Cabbage, Broccoli, Red Onions, Daikon radish
Kroger (QFC and Fred Meyer) brand, BROCCOLI CAULI MIX KFK, Net wt. 10 oz, UPC8 2676618507 8.    Kroger Main & Vine brand, BROCCOLI CAULI MIX, Net wt. 10 oz, UPC 8 2676618751 5.    Mary's Harvest brand, Broccoli & Cauliflower,  6/12 oz. packages, UPC 8 8724180834 9.    Mary's Harvest brand. Broccoli & Cauliflower mix,  6/16 oz. packages, UPC 8 8724180423 5.    INGREDIENTS: Broccoli & Cauliflower
713/10 oz. packages; 3 cases (6/12 oz. packages); 3 cases (6/16 oz. packages)
Mary's Harvest brand, Vegetable Tray Rectangle, 4/40 oz. packages, UPC 0 9250475701 6.    Mary's Harvest brand, Vegetable Tray Rectangle,  4/18 oz packages,  UPC 0 9250475712 2.    Ingredients: Celery, Grape Tomatoes, Sugar Snap Peas, Broccoli, Carrots, and Ranch Dip.
12 cases (4/40 oz. packages) and 34 cases (4/18 oz. packages)
Kroger QFC, Tandoori Grain & Vegetable Salad, net wt. 10 oz, UPC 8 267661445 3.
SKU 081223, Trader Joes Asian Stir Fry, 12/18 oz packages, UPC 812238    Ingredients Statement: Green Pepper, Broccoli, Red Pepper, Snap Peas, Snow Peas Pods, White Onion, Red Onion, Mushrooms, Carrots, Bok Choy, Bamboo Shoot, Baby Corn, and Water Chestnut.
Healthy 8 Chopped Veggie Mix, Trader Joe's, 12/16 oz packages, UPC 949002.    Ingredients Statement: Broccoli, Carrots, Green Cabbage, Red Cabbage, Jicama, Green Bell Pepper, Radish, Celery
Zydot Ultimate Blend Detox Drink Natural Tropical Ice Flavor 32 fl. oz. (946 ml) and 16 fl. oz. (473 ml) packaged in clear plastic bottles
CA, WV, FL.  The five cases that were shipped to WV and FL were determined to still be intact prior to issuing press release.
Taylor Farms Creamy  Homestyle Coleslaw Kit, dressing included.  Green Cabbage, Carrots, Red Cabbage and Creamy coleslaw dressing. Triple washed and ready to enjoy.    Salad Net. WT. 11.5 oz. , Dressing NET WT. 3. FL. oz.   UPC: 030223040637
One production lot of Creamy Homestyle Coleslaw kit was inadvertently packed with organic dressing packet which contains egg and milk.  Only egg is declared on product labeling.
lot code: TFRS212A07C;  Best if Used by: 08-16-2017.
US Distribution to the states of :  NC, UT, OR, NY,TX, GA, NJ and FL.
Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings.
Apheresis products, in which platelet yield and component preparation did not meet specifications, were distributed.
LifeSouth Community Blood Centers Inc - Birmingham Region
Apheresis product, in which platelet yield did not meet specifications, was distributed.
Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center
CYCLOSPORIN (VET) *CORN OIL* 1% Ophthalmic solution, 1%, RX only, 15mL Plastic/Multiple Dose vial
The firm is recalling sterile compounded animal drug within expiry due to lack of assurance of sterility.
New York, New Jersey, Massachusetts, Virginia, Maryland and Virginia
Wegmans Peach Crostata, Large, Net Wt. 23 oz. and 6 oz..  (In-Store Bakery)
Product contains undeclared soy lecithin.
Sell by: August 6, 2017 & August 10, 2017
Wegmans Nectarine Crostata, Large, Net Wt. 23 oz. and 6 oz..  (In-Store Bakery)
Wegmans Apple Crostata, Large, Net Wt. 23 oz. and 6 oz.  (In-Store Bakery)
Wegmans Apple Cranberry Crostata, Large, Net Wt. 23 oz. and 6 oz..  (In-Store Bakery)
GRANDMA'S HERBS CHOLESTEROL SUPPORT, Dietary Supplement, 100 Capsules 480 mg. Packaging:  PET plastic bottles, UPC# 714938 00046
Royal Mills, Iced Cappuccino, Premium Coffee.  11.0 FL. OZ. (325 ml) 2-piece aluminum can;  Made in Hawaii.  UPC: 0 73366 12755
Firm received complaints of sour taste, off odor and sediment in one lot of canned iced Cappuccino.
IHJUN15181452 ~ 1456 (Best By Code: ITO EN Hawaii JUN 15 2018, military time);  P061517CAP - (Production Code: Production 06 1517 CAPpuccino)
The Best Bar Ever, Peanut Butter Crunch, 1.41 oz., 40 gm.
The Best Bar Ever initiated a voluntary recall of the Peanut Butter Crunch flavor (40g size) because the individual wrapper mistakenly has a gluten-free logo on the label.  The wrapper for Peanut Butter Crunch flavor (40g size), had a gluten-free logo on the individual wrapper label.  The ingredient listing and allergen statements are correct.  The only issue is the gluten-free icon was not supposed to be on that flavor.
UPC: 855246005254  1,137 cartons produced on 7/18/17, lot code 071817  92 cartons produced on 6/29/17, lot code 062917A  720 cartons produced on 6/29/17, lot code 062917B  Manufactured: 06/29/17 to 07/18/17
Rainbow Carrot and Quinoa Salad, ready to eat product, packaged in one pint clear plastic deli containers, sold at random weight. UPC 252383-001604.
Rainbow Carrot and Quinoa Salad, packaged in one pint clear plastic deli containers, is recalled due to undeclared wheat and pecans.  Pecan pieces s are visually seen through clear containers.
Packed on Aug 13, 17; Sell by Aug 18, 17.
Nationwide Distribution to NJ, TN, NY, KS, OH, CA,
Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
American National Red Cross (The), Lewis and Clark Region
Plateletpheresis product, not meeting product specifications, was distributed.