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-1392-2012 | BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green... | Biocare Medical LLC | NJT | ||
| Z-0133-2013 | Class II | DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog... | DePuy Mitek, Inc. | GEI | |
| Z-1356-2012 | Stryker Secure Model 3221, 230 V- 50/60 Hz, 500 lbs (227 Kg) Stryker, Kalamazoo, MI... | Stryker Medical | FNL | ||
| Z-1361-2012 | Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Systems. Brilliance 64 Model#... | Philips North America LLC | JAK | ||
| Z-1351-2012 | Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number... | Straumann USA, LLC | NDP | ||
| Z-1355-2012 | Stryker Critical Care Bed Model 2031, 230 V , 50/60 Hz, Max Load = 225 Kg,, Stryker... | Stryker Medical | FNL | ||
| Z-1386-2012 | ACCU-CHEK Aviva Nano Blood Glucose Meter No product labeling, beyond the labels applied... | Roche Diagnostics GmbH | NBW | ||
| Z-1338-2012 | Medtronic, Model 8870, Application Software Card is part of the SynchroMed II Drug... | Medtronic Neuromodulation | LKK | ||
| Z-1426-2012 | PFC Steinman Pin/Drill Pack Sterile (WPC 667-2012) Drill Bit and Steinman Pin Packet (1... | Depuy Orthopaedics Inc. | LXH | ||
| Z-1388-2012 | Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of... | Roche Diagnostics GmbH | MMI | ||
| Z-1387-2012 | Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac... | Roche Diagnostics GmbH | MMI | ||
| Z-1354-2012 | Stryker Secure 3002, 115 V ~ 60 Hz, 500 lbs ( 227Kg), Stryker, Kalamazoo, MI 49001... | Stryker Medical | FNL | ||
| Z-1353-2012 | Stryker Epic Zoom Critical Care Bed -Model 2040, 115 V, 500 lbs ( 227 Kg) Stryker... | Stryker Medical | FNL | ||
| Z-1352-2012 | Stryker Epic Critical Care Bed (Model 2030), Stryker, Portage, MI 49002 Product... | Stryker Medical | FNL | ||
| Z-2308-2012 | Class II | Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth... | Princeton BioMeditech Corp. | GNX | |
| Z-2307-2012 | Class II | Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt... | Princeton BioMeditech Corp. | GNX | |
| Z-2306-2012 | Class II | Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA... | Princeton BioMeditech Corp. | GNX | |
| Z-1283-2012 | Philips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified... | Philips Medical Systems DMC GmbH | JAA | ||
| Z-2336-2012 | Class III | BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling... | Freudenberg Medical, LLC | EWL | |
| Z-1500-2012 | AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended... | Zeus Scientific LLC | LJY | ||
| Z-2237-2012 | Class II | i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic... | Abbott Medical | MMI | |
| Z-1934-2012 | Class II | S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments... | Aesculap Inc | HWW | |
| Z-1357-2012 | The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary... | Acumed LLC | HSB | ||
| Z-1366-2013 | Class II | Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product... | Depuy Orthopaedics Inc. | LPH | |
| Z-1078-2013 | Class II | GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for... | GE Healthcare | KPS | |
| Z-1390-2012 | Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test... | Siemens Healthcare Diagnostics Inc. | JFT | ||
| Z-1250-2012 | Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Ventricular... | Medtronic, Inc. | LWS | ||
| Z-1249-2012 | Medtronic EnTrust, Single Chamber Implantable, Cardioverter Defibrillator with... | Medtronic, Inc. | LWS | ||
| Z-1248-2012 | Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Atrial and... | Medtronic, Inc. | LWS | ||
| Z-1339-2012 | Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | ||
| Z-0911-2013 | Class III | BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes... | Becton Dickinson & Co | JKA | |
| Z-1467-2012 | Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of... | Alere San Diego, Inc. | MMI | ||
| Z-1466-2012 | Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the... | Alere San Diego, Inc. | MMI | ||
| Z-1365-2012 | Monaco Radiation Treatment Planning System, Version 3.10.00. Planning of radiation... | Elekta Limited | MUJ | ||
| Z-1336-2012 | BacT/ALERT Blood Collection Adapter The BacT/ALERT Adapter Cap is intended for use as an... | bioMerieux, Inc. | GIM | ||
| Z-1211-2012 | MPI Rapid Response HUT Table, Model #RRHUT 1017. The firm name on the label is Medical... | Medical Positioning Inc | LGX | ||
| Z-1210-2012 | MPI Rapid Response HUT Table, Model #RRHUT 1217 with Dual 2 Way Drop Section. The firm... | Medical Positioning Inc | LGX | ||
| Z-1627-2012 | The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear... | Ethicon Endo-Surgery Inc | GDW | ||
| Z-1653-2012 | Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is... | Pharmaceutical Innovations, Inc. | MUI | ||
| Z-1652-2012 | Other-Sonic Generic Ultrasound Transmission Gel 250 mL Hypoallergenic Product Usage is a... | Pharmaceutical Innovations, Inc. | MUI | ||
| Z-1481-2012 | Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460... | MEDLINE INDUSTRIES, LP - Northfield | FTL | ||
| Z-1319-2012 | Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile... | Boston Scientific Corporation | GEI | ||
| Z-2157-2012 | Class II | I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This... | Abbott Medical | GJS | |
| Z-1376-2012 | OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to... | Animas Corp. | LZG | ||
| Z-2012-2012 | Class III | Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics... | Critical Diagnostics | OYG | |
| Z-1623-2012 | a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine... | DSM Biomedical, Inc. | NPL | ||
| Z-1622-2012 | a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine... | DSM Biomedical, Inc. | NPL | ||
| Z-1621-2012 | a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine... | DSM Biomedical, Inc. | NPL | ||
| Z-1370-2012 | Hologics SecurView DX workstation, software version 7.3.0 intended for viewing... | Hologic, Inc. | LLZ | ||
| Z-1275-2012 | CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter... | Varian Medical Systems, Inc. | GEH |