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-0050-06 | Optium Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care... | Abbott Medical | NBW | ||
| Z-0049-06 | Boots Glucose Monitoring System Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc... | Abbott Medical | NBW | ||
| Z-0048-06 | Liberty Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care... | Abbott Medical | NBW | ||
| Z-0047-06 | RiteAid Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care... | Abbott Medical | NBW | ||
| Z-0046-06 | Kroger Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care... | Abbott Medical | NBW | ||
| Z-0045-06 | ReliOn Ultima Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes... | Abbott Medical | NBW | ||
| Z-0044-06 | Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care... | Abbott Medical | NBW | ||
| Z-0043-06 | Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes... | Abbott Medical | NBW | ||
| Z-0042-06 | FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott... | Abbott Medical | NBW | ||
| Z-1031-05 | Depuy brand LCS Complete metal backed patella, cemented, LRG+; REF 1294-09-770. | Depuy Orthopaedics Inc. | NJL | ||
| Z-1030-05 | Depuy brand LCS Complete metal backed patella, cemented, LRG; REF 1294-09-760. | Depuy Orthopaedics Inc. | NJL | ||
| Z-1029-05 | Depuy brand LCS Complete metal backed patella, cemented, STD+; REF 1294-09-750. | Depuy Orthopaedics Inc. | NJL | ||
| Z-1028-05 | Depuy brand LCS Complete metal backed patella, cemented, STD; REF 1294-09-740. | Depuy Orthopaedics Inc. | NJL | ||
| Z-1027-05 | Depuy brand LCS Complete metal backed patella, porocoat, LRG+; REF 1294-09-670. | Depuy Orthopaedics Inc. | NJL | ||
| Z-1026-05 | Depuy brand LCS Complete metal backed patella, porocoat, LRG; REF 1294-09-660. | Depuy Orthopaedics Inc. | NJL | ||
| Z-1025-05 | Depuy brand LCS Complete metal backed patella, porocoat, STD+; REF 1294-09-650. | Depuy Orthopaedics Inc. | NJL | ||
| Z-0961-05 | Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890 | Abbott Medical | CAH | ||
| Z-1024-05 | Depuy brand LCS Complete metal backed patella, porocoat, STD; REF 1294-09-640. | Depuy Orthopaedics Inc. | NJL | ||
| Z-1370-05 | ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter. | Roche Diagnostics GmbH | NBW | ||
| Z-0067-06 | Remington Medical, Inc., 8 French-Sheath Only, Size 8 French, Single Use. Ethylene Oxide... | Remington Medical | GWG | ||
| Z-0066-06 | Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets, Size 8 French, Sterile... | Remington Medical | GWG | ||
| Z-0065-06 | Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile... | Remington Medical | GWG | ||
| Z-0975-05 | RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560 | Straumann USA, LLC | DZE | ||
| Z-0924-05 | Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807 | Plus Orthopedics | JWH | ||
| Z-0926-05 | The Maestor System 225-312, Profile Abutment for Cement, 5mm | BioHorizons Implant Systems Inc | NDP | ||
| Z-0925-05 | The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm | BioHorizons Implant Systems Inc | NDP | ||
| Z-1379-05 | The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED... | Exactech, Inc. | JWH | ||
| Z-0972-05 | Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit... | Boston Scientific Corporation | KGC | ||
| Z-0971-05 | Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit... | Boston Scientific Corporation | KGC | ||
| Z-0970-05 | Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit... | Boston Scientific Corporation | KGC | ||
| Z-0969-05 | Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit... | Boston Scientific Corporation | KGC | ||
| Z-0968-05 | Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit... | Boston Scientific Corporation | KNT | ||
| Z-0967-05 | Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit... | Boston Scientific Corporation | KNT | ||
| Z-0966-05 | Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24... | Boston Scientific Corporation | KGC | ||
| Z-0965-05 | Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24... | Boston Scientific Corporation | KGC | ||
| Z-0964-05 | Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20... | Boston Scientific Corporation | KGC | ||
| Z-0963-05 | Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20... | Boston Scientific Corporation | KGC | ||
| Z-0962-05 | Boston Scientific brand Low Profile PEG (percutaneous endoscopic gastrostomy tubes) Kit... | Boston Scientific Corporation | KGC | ||
| Z-1446-06 | BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date... | Becton Dickinson & Co | GKE | ||
| Z-1147-2007 | ISOLOC 4.2 Software Part Number NT-NW-425-520. Image guided radiation treatment software. | Northwest Medical Physics Equipment, Inc. | IYE | ||
| Z-1315-06 | Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in... | Applied Biotech Inc | LCM | ||
| Z-1048-05 | Baxter Interlink System Huber Needle Extension Set; a sterile 10'' fluid pathway with an... | Baxter Healthcare Corporation | FPA | ||
| Z-1864-2008 | Triathlon Femoral Sizer - The Femoral sizer was developed for use with the Triathlon... | Howmedica Osteonics Corp | LXH | ||
| Z-0614-05 | Bac T/ALERT 3D 60 | bioMerieux, Inc. | MDB | ||
| Z-0613-05 | Bac T/ALERT 3D Combination Module | bioMerieux, Inc. | MDB | ||
| Z-0612-05 | Bac T/ALERT 3D Control Module | bioMerieux, Inc. | MDB | ||
| Z-1090-05 | Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5... | Warsaw Orthopedic, Inc. | MAX | ||
| Z-1062-05 | Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K... | B Braun Medical Inc | DYB | ||
| Z-1367-05 | Depuy P.F.C. E Knee System, stabilized plus tibial insert (STAB PLUS); polyethylene... | Depuy Orthopaedics Inc. | NJL | ||
| Z-1366-05 | Depuy P.F.C. E Knee System, stabilized plus tibial insert (STAB PLUS); polyethylene... | Depuy Orthopaedics Inc. | NJL |