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-1744-2009 | Stryker PainPump, 1-day infusion kit, 120 mL infusion kit (4.16 mL/hr), sterile, Stryker... | Stryker Corp. | FRN | ||
| Z-1743-2009 | Stryker PainPump, 2-day infusion kit with ExFen 5.0", 120 mL infusion kit (2.08 mL/hr)... | Stryker Corp. | FRN | ||
| Z-1742-2009 | Stryker PainPump, 2-day infusion kit with ExFen 2.5", 120 mL infusion kit (2.08 mL/hr)... | Stryker Corp. | FRN | ||
| Z-1741-2009 | Stryker PainPump, 2-day infusion kit, 120 mL infusion kit (2.08 mL/hr), sterile, Stryker... | Stryker Corp. | FRN | ||
| Z-1740-2009 | Stryker PainPump, 5-day infusion kit, 120 mL infusion kit (0.83 mL/hr), sterile, Stryker... | Stryker Corp. | FRN | ||
| Z-1739-2009 | Stryker PainPump base kit, 120 mL infusion kit, sterile, Stryker Instruments, Kalamazoo... | Stryker Corp. | FRN | ||
| Z-1738-2009 | Stryker ExFen 5.0" extended fenestration catheter set for PainPump, sterile, Stryker... | Stryker Corp. | FRN | ||
| Z-1737-2009 | Stryker ExFen 2.5" extended fenestration catheter set for PainPump, sterile, Stryker... | Stryker Corp. | FRN | ||
| Z-1736-2009 | Stryker PainPump catheter and split introducer needle, sterile, Stryker Instruments... | Stryker Corp. | FRN | ||
| Z-1780-2010 | St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized... | Abbott Medical | OCL | ||
| Z-1013-2010 | Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set... | Bio-Rad Laboratories Inc. | LCP | ||
| Z-0421-2010 | Kuschall K Junior Manual wheelchair | Invacare GmbH | IOR | ||
| Z-2559-2011 | Focal Radiation Treatment Planning System, Focal Release 4.34.00 through 4.50.00. For... | Elekta Limited | MUJ | ||
| Z-1638-2010 | BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company... | Becton Dickinson & Co | HTS | ||
| Z-1598-2009 | Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road... | Wilson-Cook Medical Inc. | KNS | ||
| Z-1794-2009 | Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following... | CareFusion 303, Inc | FRN | ||
| Z-1793-2009 | Alaris Pump Module, Model 8100. | CareFusion 303, Inc | FRN | ||
| Z-1792-2009 | The Alaris PC Unit, Model 8015 (manufactured or serviced between April 2008 and January... | CareFusion 303, Inc | FRN | ||
| Z-1791-2009 | The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software... | CareFusion 303, Inc | FRN | ||
| Z-1790-2009 | The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software... | CareFusion 303, Inc | FRN | ||
| Z-1946-2009 | ARJO Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient... | Arjohuntleigh AB | FSA | ||
| Z-2025-2009 | ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Peripheral Stent... | Medtronic, Inc. | FGE | ||
| Z-2039-2009 | Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant... | Advanced Bionics LLC | MCM | ||
| Z-2024-2009 | ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Peripheral Stent... | Medtronic, Inc. | FGE | ||
| Z-2023-2009 | ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Biliary Stent System... | Medtronic, Inc. | FGE | ||
| Z-2022-2009 | ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Biliary Stent System... | Medtronic, Inc. | FGE | ||
| Z-2006-2009 | Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN... | Roche Diagnostics GmbH | NBW | ||
| Z-2005-2009 | Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN... | Roche Diagnostics GmbH | NBW | ||
| Z-1936-2009 | FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with... | Abbott Medical | NBW | ||
| Z-1703-2009 | Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis... | Howmedica Osteonics Corp | MRA | ||
| Z-2048-2017 | Class II | NDI P7 Position Sensor, Stereotaxic Instrument | Zimmer CAS | HAW | |
| Z-1630-2010 | CELL-DYN 1800, list numbers 07H77-01, 07H77-03, manufactured by Abbott Hematology, Santa... | Abbott Medical | gkz | ||
| Z-1629-2010 | CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by... | Abbott Medical | gkz | ||
| Z-1628-2010 | CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology... | Abbott Medical | gkz | ||
| Z-1700-2009 | Zimmer Coonrad/Morrey total elbow cement restrictor with nozzle, 1 - 16 mm, 1 - 25 mm... | Zimmer GmbH | JDI | ||
| Z-1699-2009 | Zimmer Allen medullary cement plugs, 1 - 20 dia. flange/10 mm dia. core, 1 - 24 mm dia... | Zimmer GmbH | JDI | ||
| Z-1698-2009 | Zimmer Pulsavac Wound Debridement System high capacity intramedullary brush tip, sterile... | Zimmer GmbH | FQH | ||
| Z-1136-2010 | PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek... | Polymer Technology Systems | CHH | ||
| Z-1627-2010 | Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System... | Endotec, Inc. | JWH | ||
| Z-1626-2010 | TMJ Components: Right Ramus Component - DelCristo Catalog: 09-11-0215, TMJ - Shah... | Endotec, Inc. | JWH | ||
| Z-1625-2010 | Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System... | Endotec, Inc. | JWH | ||
| Z-1624-2010 | Endotec Prothesis Ankle, Titanium Alloy, Sterilized. BP Ankle System, Talar Ankle... | Endotec, Inc. | JWH | ||
| Z-1623-2010 | Endotec Prothesis Hip, Titanium Alloy, Sterilized. Acetabular Bearing, BP Hip System... | Endotec, Inc. | JWH | ||
| Z-1622-2010 | Endotec Prosthesis Shoulder, Titanium Alloy, Sterilized Modular Femoral Stem BP Shoulder... | Endotec, Inc. | JWH | ||
| Z-1870-2009 | GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/72 in, REF M1089028, M1087972... | GE Healthcare | CAI | ||
| Z-1621-2010 | Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented... | Endotec, Inc. | JWH | ||
| Z-1696-2009 | Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140, Rx only... | Smith & Nephew, Inc. | LPQ | ||
| Z-1695-2009 | Exogen 4000+ Ultrasound Bone Healing System, SAFHS, Part Numbers 71034100 and 71034101... | Smith & Nephew, Inc. | LPQ | ||
| Z-1702-2009 | Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile... | Zimmer GmbH | HSB | ||
| Z-1701-2009 | Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF... | Zimmer GmbH | HSB |