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-2014-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS... | Abbott Medical | GKZ | ||
| Z-2146-2011 | Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile... | Baxter Healthcare Corporation | MEB | ||
| Z-0639-2012 | TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended... | Ormco/Sybronendo | DZC | ||
| Z-2101-2011 | Argon Medical Devices, Arterial Line Kit/1, 18ga x 6", Part Number 498447, Lot number... | Argon Medical Devices, Inc | FTN | ||
| Z-2100-2011 | Argon Medical Devices, Arterial Line Kit 20ga x 3", Part Number 498421B, Lot number... | Argon Medical Devices, Inc | FTN | ||
| Z-2099-2011 | Argon Medical Devices Arterial Line Kit, 18ga x 6", Part Number 498412B, Lot number... | Argon Medical Devices, Inc | FTN | ||
| Z-2098-2011 | Argon Medical Devices, Arterial Line Kit, Part Number 498410B, 20gax6", Lot number... | Argon Medical Devices, Inc | FTN | ||
| Z-2097-2011 | Argon Medical Devices, Catheter Introducer Kit 5F, Part Number 496190A, Lot number... | Argon Medical Devices, Inc | FTN | ||
| Z-2096-2011 | Argon Medical Devices, Arterial Line Kit, 18ga x 6", Part Number 498443, Lot number... | Argon Medical Devices, Inc | FTN | ||
| Z-2095-2011 | Argon Medical Devices, Arterial Line Kit, Arterial Catheter Mini Kit, 20GX3in, Part... | Argon Medical Devices, Inc | FTN | ||
| Z-2094-2011 | Argon Medical Devices Arterial Line Kit, 20ga x 1.75", Part Number 498418, Lot number... | Argon Medical Devices, Inc | FTN | ||
| Z-2093-2011 | Argon Medical Devices, Arterial Line Kit, 20ga x 3", Part Number 498411B, Lot number... | Argon Medical Devices, Inc | FTN | ||
| Z-2092-2011 | Argon Medical Devices Arterial Line Kit/1, 18ga x 3", Part Number 498110, Lot numbers... | Argon Medical Devices, Inc | FTN | ||
| Z-2091-2011 | Argon Medical Devices, Arterial Line Kit/1, 20ga x 3", Part Number 498106, Lot numbers... | Argon Medical Devices, Inc | FTN | ||
| Z-2090-2011 | Argon Medical Devices, Arterial Line Kit/1 18ga x 6", Part Number 498104, Lot numbers... | Argon Medical Devices, Inc | FTN | ||
| Z-2089-2011 | Argon Medical Devices, Arterial Line Kit, Arterial Catheter Mini Kit 20gax6in, Part... | Argon Medical Devices, Inc | FTN | ||
| Z-2088-2011 | Argon Medical Devices Arterial Line Kit/1 20ga x 6", Part Number 498100, Lots 99767185... | Argon Medical Devices, Inc | FTN | ||
| Z-2087-2011 | Argon Medical Devices Catheter Introducer Kit, One-Piece/Tuohy-Borst Catheter Introducer... | Argon Medical Devices, Inc | FTN | ||
| Z-2086-2011 | Part Number 496311, Lot Number 99768100 Multi-purpose Kit blister tray coupled with... | Argon Medical Devices, Inc | FTN | ||
| Z-2085-2011 | Argon Medical Devices Catheter Introducer Kit, PCI Kit with Feather Dilator - Pediatric... | Argon Medical Devices, Inc | FTN | ||
| Z-2084-2011 | Argon Medical Devices, Catheter Introducer Kit, Argon PCI Kit with Feather Dilator... | Argon Medical Devices, Inc | FTN | ||
| Z-1960-2011 | STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid... | STERIS Corporation | MED | ||
| Z-2083-2011 | Argon Medical Devices Catheter Introducer Kit, PCI 5 Kit 7F, Part Number 496183, Lot... | Argon Medical Devices, Inc | FTN | ||
| Z-1997-2011 | Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION PATELLA... | Zimmer GmbH | MBH | ||
| Z-1996-2011 | Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION PATELLA... | Zimmer GmbH | MBH | ||
| Z-1995-2011 | Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION FEMORAL... | Zimmer GmbH | MBH | ||
| Z-1994-2011 | Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION DISTAL... | Zimmer GmbH | MBH | ||
| Z-1993-2011 | Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION... | Zimmer GmbH | MBH | ||
| Z-1992-2011 | Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION... | Zimmer GmbH | MBH | ||
| Z-1991-2011 | Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION... | Zimmer GmbH | MBH | ||
| Z-1990-2011 | Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION MODULAR... | Zimmer GmbH | MBH | ||
| Z-1989-2011 | Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION QUICK-CONNECT... | Zimmer GmbH | MBH | ||
| Z-1988-2011 | Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION PATELLA PEG... | Zimmer GmbH | MBH | ||
| Z-1987-2011 | Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION POSTERIOR... | Zimmer GmbH | MBH | ||
| Z-1986-2011 | Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION POSTERIOR... | Zimmer GmbH | MBH | ||
| Z-1985-2011 | Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION, FEMORAL AND... | Zimmer GmbH | MBH | ||
| Z-1901-2011 | Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid... | Gambro Renal Products | KDI | ||
| Z-2174-2011 | NEXGEN COMPLETE KNEE SOLUTION FEMORAL REPLACEMENT JAW FOR USE WITH FEMORAL AND... | Zimmer GmbH | MBH | ||
| Z-2173-2011 | NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, NONSTERILE... | Zimmer GmbH | MBH | ||
| Z-2884-2011 | LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i Castable cylinders... | ZimVie US Corp LLC | NHA | ||
| Z-2226-2011 | SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 The Beckman... | Siemens Healthcare Diagnostics Inc. | JIT | ||
| Z-2225-2011 | Universal Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra... | Integra LifeSciences Corporation | GFD | ||
| Z-2058-2011 | R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 62 MM O.D., REF 71338962... | Smith & Nephew, Inc. | MRA | ||
| Z-2057-2011 | R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 56 MM O.D., REF 71338956... | Smith & Nephew, Inc. | MRA | ||
| Z-2056-2011 | R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 54 MM O.D., REF 71338954... | Smith & Nephew, Inc. | MRA | ||
| Z-2055-2011 | R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 52 MM O.D., REF 71338952... | Smith & Nephew, Inc. | MRA | ||
| Z-2054-2011 | R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM O.D. 55 MM O.D., REF 71338950... | Smith & Nephew, Inc. | MRA | ||
| Z-2053-2011 | R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM I.D. 48 MM O.D., REF 71338948... | Smith & Nephew, Inc. | MRA | ||
| Z-2082-2011 | BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. Product is labeled in part... | Bio-Rad Laboratories Inc. | LSE | ||
| Z-3207-2011 | Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number... | Synthes GmbH | NKB |