Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0418-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 380 x 13 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0417-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 360 x 13 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0416-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 340 x 13 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0415-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 420 x 11 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0414-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 400 x 11 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0413-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 380 x 11 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0412-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 360 x 11 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0411-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 340 x 11 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0410-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 320 x 11 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0409-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 400 x 9 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0408-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 380 x 9 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0407-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 390 x 9 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0406-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 340 x 9 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0405-04 | Depuy brand ACE trochanteric nail; sterile, long, right hip, 320 x 9 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0404-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 420 x 13 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0403-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 13 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0402-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 380 x 13 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0401-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 360 x 13 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0400-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 340 x 13 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0399-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 420 x 11 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0398-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 11 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0397-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 380 x 11 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0396-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 360 x 11 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0395-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 340 x 11 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0394-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 9 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0393-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 380 x 9 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0392-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 360 x 9 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0391-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 340 x 9 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0390-04 | Depuy brand ACE trochanteric nail; sterile, long, left hip, 320 x 11 x 130; Product... | Depuy Orthopaedics Inc. | HSB | ||
| Z-0548-04 | CryoValve Pulmonary Valve and Conduit | Artivion, Inc. | MIE | ||
| Z-0345-04 | Prostatron Praktis Type II for Transurethral Microwave Thermotherapy. The Prostatron is... | Urologix, LLC | MEQ | ||
| Z-1375-04 | ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496. | Remel Inc | MHI | ||
| Z-0513-04 | Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test... | Diamedix Corp. | LIP | ||
| Z-0306-04 | Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630. | GE Healthcare | IYB | ||
| Z-0506-04 | AG-920RA Multi-gas unit analyzer | Nihon Kohden America Inc | CCK | ||
| Z-0511-04 | ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL... | Abbott Medical | DJR-- | ||
| Z-0510-04 | TDx/TDxFLx Methadone, list 9676-60; Abbott Laboratories, Diagnostics Division, Abbott... | Abbott Medical | DJR-- | ||
| Z-0509-04 | TDx/TDxFLx Salicylate, list 9533-60; Abbott Laboratories, Diagnostics Division, Abbott... | Abbott Medical | DKJ-- | ||
| Z-0508-04 | TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott... | Abbott Medical | DIC-- | ||
| Z-0507-04 | TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories... | Abbott Medical | DCK | ||
| Z-0341-04 | Baxter Lineo Opticap Disconnect Cap, product codes R5C4599Q (English) and N5C4599Q (dual... | Baxter Healthcare Corporation | KGZ | ||
| Z-0340-04 | Baxter HomeChoice Automated PD Set with Lineo Connector, 4-prong, product codes R5C4479Q... | Baxter Healthcare Corporation | KGZ | ||
| Z-0841-04 | Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency... | Gyrus ACMI, Inc. | GEI | ||
| Z-0232-04 | Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged... | Danatech Medical Systems Inc | MAA | ||
| Z-0241-04 | Phototherapy Lamp, Model 9001W501JE | Fisher & Paykel Healthcare, Inc. | LBI | ||
| Z-0299-04 | Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated... | Ortho-Clinical Diagnostics, Inc. | DHX | ||
| Z-0296-04 | POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x... | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC | DCK | ||
| Z-0295-04 | POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No... | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC | DCK | ||
| Z-0387-04 | Products are various dental surgical drills packed in a sealed tray and labeled as... | ZimVie US Corp LLC | DZI | ||
| Z-0386-04 | Products are various dental surgical drills packed in a sealed tray and labeled as... | ZimVie US Corp LLC | DZI |