FDA recalls, April 2013: 314 published

143 different companies appear this month.

Risk classification: Class I: 37 · Class II: 230 · Class III: 47

Same month, other agencies:CPSC 25 recallsNHTSA 59 recalls

Recalls this month

DateProduct
April 24, 2013Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the tr…Z-1135-2013Edwards Lifesciences, LLC
April 24, 2013Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vi…Z-1144-2013Vital Images, Inc.
April 24, 2013Canned mushrooms, #10 cans (Brites, not labeled)F-1327-2013L. K. Bowman, Incorporated
April 24, 2013ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended t…Z-1052-2013Stryker Howmedica Osteonics Corp.
April 24, 2013Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED…D-249-2013Teva Pharmaceuticals USA, Inc.
April 24, 2013The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with St…Z-1127-2013Synvasive Technology Inc
April 24, 2013ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the q…Z-1122-2013Siemens Healthcare Diagnostics, Inc
April 24, 2013Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 …Z-1105-2013Siemens Medical Solutions USA, Inc
April 24, 2013Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged…Z-1126-2013Accuray Incorporated
April 24, 2013Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (ND…D-259-2013Pfizer Inc.
April 24, 2013Little Mermaid Brand Smoked Herring.F-1316-2013Little Mermaid Smokehouse
April 24, 2013ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the q…Z-1120-2013Siemens Healthcare Diagnostics, Inc
April 24, 2013Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeo…Z-1143-2013Elana, Inc.
April 24, 2013HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit Fo…Z-1147-2013Transonic Systems Inc
April 24, 2013Fructus Lycii (400g). Dried Medlar (Net Wt: 14.11 oz (400G). Ingredients: Dried Medlar.…F-1322-2013Tristar Food Wholesale Co Inc
April 24, 2013GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 …Z-1133-2013GE Healthcare, LLC
April 24, 2013Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software …Z-1103-2013Integra LifeSciences Corp.
April 24, 2013Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC uni…Z-1098-2013Carefusion Corporation
April 24, 2013GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system tha…Z-1137-2013GE Healthcare, LLC
April 24, 2013Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado …Z-1115-2013Synvasive Technology Inc
April 24, 2013buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle…D-248-2013Actavis South Atlantic LLC
April 24, 2013Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (ND…D-258-2013Pfizer Inc.
April 24, 2013EphBurn 25, 90 count bottle with red capsulesF-1325-2013Brand New Energy, LLC
April 24, 2013Trader Joe's Tomato Basil Hummus Dip 7 oz., 24 units/case, SKU 21953.F-1334-2013Two Chefs On A Roll, Inc
April 24, 2013VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. …Z-1107-2013Ortho-Clinical Diagnostics
April 24, 2013Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vi…Z-1151-2013Siemens Healthcare Diagnostics, Inc.
April 24, 2013Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC u…Z-1112-2013Carefusion Corporation
April 24, 2013Trader Joe's Three Layer Hummus Dip 12 oz., 12 units/case, SKU 80867.F-1330-2013Two Chefs On A Roll, Inc
April 24, 2013LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. Testi…Z-1130-2013Lifescan Inc
April 24, 2013ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the q…Z-1121-2013Siemens Healthcare Diagnostics, Inc
April 24, 2013Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted…D-264-2013Lupin Pharmaceuticals Inc.
April 24, 2013VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System R…Z-1106-2013Ortho-Clinical Diagnostics
April 24, 2013Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (N…D-257-2013Pfizer Inc.
April 24, 2013Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (ND…D-256-2013Pfizer Inc.
April 24, 2013ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the …Z-1119-2013Siemens Healthcare Diagnostics, Inc
April 24, 2013Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitati…Z-1139-2013Alere San Diego, Inc.
April 24, 2013Fresh & Easy Organic 100% Apple Juice from concentrate, 64 oz, 8 units/case. UPC/Barco…F-1328-2013Fresh And Easy
April 24, 2013Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (ND…D-261-2013Pfizer Inc.
April 24, 2013The GemStar Pump is a small and lightweight, single channel infusion device designed for …Z-1117-2013Hospira Inc.
April 24, 2013Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Ho…D-262-2013Hospira Inc.
April 24, 2013Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the tr…Z-1134-2013Edwards Lifesciences, LLC
April 24, 2013Trader Joe's Hummus Salad Dressing 12 oz., 12 units/case, SKU 96752.F-1337-2013Two Chefs On A Roll, Inc
April 24, 2013LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02…Z-1129-2013Lifescan Inc
April 24, 2013IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Ar…Z-1109-2013Intuitive Surgical, Inc.
April 24, 2013GERBER¿ Pure Water (1 Plastic Gallon)F-1324-2013Nestle Puerto Rico Inc
April 24, 2013Metal cans; labeled as containing 29 oz of pinto beans packed in water and saltF-1323-2013La Preferida Inc
April 17, 2013MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MR…Z-1101-2013Toshiba American Medical Systems Inc
April 17, 2013Canned Apricot in Light Syrup or canned Apricot in Heavy Syrup. The PDP reads "HOOD-CR…F-1314-2013Sage Creek Inc
April 17, 2013Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT…Z-1085-2013Medtronic MiniMed
April 17, 2013Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per…D-246-2013Teva Pharmaceuticals USA, Inc.

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