FDA recalls, February 2014: 375 published

147 different companies appear this month.

Risk classification: Class I: 32 · Class II: 321 · Class III: 22

Same month, other agencies:FSIS 10 recallsNHTSA 53 recalls

Recalls this month

DateProduct
February 26, 2014Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro …Z-0984-2014Beckman Coulter Inc.
February 26, 2014Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid devel…Z-0988-2014Siemens Hearing Instruments, Inc
February 26, 2014CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-…Z-1045-2014Biosense Webster, Inc.
February 26, 2014MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001Z-1018-2014Zimmer, Inc.
February 26, 2014GC Medium 5-5# Z, Product Item Number 1055-3. Packaged in sealed poly film pouches. All …F-1510-2014El Encanto, Incorporated
February 26, 20146 DEGREE COCR FEM HEAD 36Z-1034-2014Zimmer, Inc.
February 26, 2014Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D …Z-1004-2014Zimmer, Inc.
February 26, 2014Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: T…Z-1063-2014Implantech Associates Inc
February 26, 2014GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking St…Z-0982-2014GE Healthcare, LLC
February 26, 2014Kinnikinnick Original Homestyle Waffles Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box UP…F-1534-2014Cal-Fresh Produce
February 26, 2014M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with…Z-1007-2014Zimmer, Inc.
February 26, 2014HGP II ACETABULAR CUP MODZ-1026-2014Zimmer, Inc.
February 26, 2014Bueno GC NM Mild 6-56oz Z, Product Item Number 1044-2. Packaged in plastic containers. …F-1508-2014El Encanto, Incorporated
February 26, 2014GC NO LABEL Hot 5-5# Z, Product Item Number 1056-0. Packaged in sealed poly film pouches.…F-1511-2014El Encanto, Incorporated
February 26, 2014FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-L…Z-1003-2014Zimmer, Inc.
February 26, 2014NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500Z-1020-2014Zimmer, Inc.
February 26, 2014RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting…Z-1008-2014Zimmer, Inc.
February 26, 2014TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY …Z-1024-2014Zimmer, Inc.
February 26, 20142.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 …Z-1041-2014Zimmer, Inc.
February 26, 2014PRESSFIT FEM ST FX 16 X 1Z-1027-2014Zimmer, Inc.
February 19, 20145 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, …Z-0974-2014Custom Medical Specialties, Inc.
February 19, 2014Kinnikinnick Gluten Free Original Homestyle Waffles Frozen Contains a logos on the packa…F-1488-2014Unified Western Grocers Inc
February 19, 2014Bread & Bun Mix, 16.4oz, Qty/pkg: 6, UPC 620133105504, NB Item 645564F-1496-2014Natures Best Inc
February 19, 2014Farm To Market Bread Co. San Francisco Sourdough, net weight 1 lb., unbleached enriched f…F-1475-2014Farm To Market Bread Co Inc
February 19, 2014BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided local…Z-0967-2014Brainlab AG
February 19, 2014VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry System…Z-0968-2014Ortho-Clinical Diagnostics
February 19, 2014Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H749391852015…Z-0971-2014Boston Scientific Corporation
February 19, 2014Horizon Medical Imaging, Picture Archive Communication System (PACS).Z-0976-2014Mckesson Information Solutions LLC
February 19, 2014D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States;…Z-0965-2014Bio-Rad Laboratories, Inc.
February 19, 2014Cinnamon and Brown Sugar Homestyle Waffles, 7.4oz, Qty/Pkg: 6, UPC 620133001998, NB Item …F-1495-2014Natures Best Inc
February 19, 2014Pancake and Waffle Mix, 16 oz, UPC 620133105122, NB Item#645556F-1493-2014Natures Best Inc
February 19, 2014Panko Style Bread Crumbs net wt. 350g 12.5 oz. gluten free, dairy free, nut freeF-1479-2014Braum's Ice Cream and Dairy
February 19, 2014***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in den…Z-0939-2014RTI Surgical, Inc.
February 19, 2014Chocolate Gift Boxes: SC 6 Oreos, SC Small 12 Chocolate, SC Small 6 chocolate Araya Arti…F-1484-2014Araya, Inc
February 19, 2014Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a pac…Z-0964-2014Stryker Howmedica Osteonics Corp.
February 19, 2014Chocolate S'mores Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (…F-1485-2014Araya, Inc
February 19, 2014Gano C'Real Spirulina, Net Wt. 450g (30gx15 sachets)F-1477-2014Gano Excel USA Inc
February 19, 2014Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The AD…Z-0940-2014Siemens Healthcare Diagnostics, Inc.
February 19, 2014Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, …Z-0977-2014Medtronic Sofamor Danek USA Inc
February 19, 2014Marshmallow in the following flavors: chocolate, coconut, cookies and cream, gingerbread,…F-1482-2014Araya, Inc
February 19, 2014Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, S…Z-0948-2014Ecolab Inc
February 19, 2014Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle,…D-1082-2014Watson Laboratories, Inc.-(Actavis) - Florida
February 19, 2014Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H7493…Z-0969-2014Boston Scientific Corporation
February 19, 2014MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm…Z-0943-2014Ecolab Inc
February 19, 2014Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Myl…D-1084-2014Mylan Pharmaceuticals Inc.
February 19, 2014enGen Track System with enGen Select v5.0 with autoverification enabled Product The VI…Z-0941-2014Ortho-Clinical Diagnostics
February 19, 2014T:slim Insulin Delivery System Insulin Infusion PumpZ-0827-2014Tandem Diabetes Care Inc
February 19, 2014Dry fruits covered in chocolate in the following flavors: orange peel, mango cayenne, pea…F-1483-2014Araya, Inc
February 19, 2014Kinnikinnick Gluten Free Pancake and Waffle Mix, gluten free, dairy free, nut free. 454 …F-1487-2014Unified Western Grocers Inc
February 19, 2014Kinnikinnick Gluten Free Cinnamon and Brown Sugar Homestyle Waffles - Frozen - gluten fre…F-1489-2014Unified Western Grocers Inc

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