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-0640-2009 | Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0639-2009 | Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0638-2009 | Terumo TenderFlow Pediatric Arterial Cannulae, 4.7 mm (14Fr) OD, with 1/4 inch vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0637-2009 | Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch non-vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0636-2009 | Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0635-2009 | Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0634-2009 | Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0633-2009 | Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0632-2009 | Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0631-2009 | Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0630-2009 | Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0952-2009 | EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained... | Epocal Inc | CEM | ||
| Z-0903-2009 | Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually... | Spectranetics Corp. | OEX | ||
| Z-0628-2009 | TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The... | Accuray Incorporated | IYE | ||
| Z-0267-2013 | Class II | Quadra S Offset Broach Handle The offset broach handle is intended to attach to the... | Medacta USA, Inc. | JDI | |
| Z-0922-2009 | GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by... | ZOLL Medical Corporation | MKJ | ||
| Z-0921-2009 | Cardio Vive 92532 AED, BURDICK Manufactured by Cardiac Science Corporation, Automated... | ZOLL Medical Corporation | MKJ | ||
| Z-0920-2009 | Cardiac Science Powerheart Automated External Defibrillator G3 9390E | ZOLL Medical Corporation | MKJ | ||
| Z-0919-2009 | Cardiac Science Powerheart Automated External Defibrillator G3 9390A | ZOLL Medical Corporation | MKJ | ||
| Z-0918-2009 | Cardiac Science Powerheart Automated External Defibrillator G3 9300E. | ZOLL Medical Corporation | MKJ | ||
| Z-0917-2009 | Cardiac Science First Save Automated External Defibrillator G3 9300C | ZOLL Medical Corporation | MKJ | ||
| Z-0916-2009 | Cardiac Science Powerheart Automated External Defibrillator G3 9300A | ZOLL Medical Corporation | MKJ | ||
| Z-0607-2009 | Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the... | Diamedix Corp. | LJB | ||
| Z-1030-2009 | Stryker Precision Oscillating Tip Saw, For use with Stryker System 6. Stryker... | Stryker Corp. | KIJ | ||
| Z-1029-2009 | Stryker Sagittal Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI... | Stryker Corp. | KIJ | ||
| Z-1028-2009 | Stryker Sagittal Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI... | Stryker Corp. | KIJ | ||
| Z-1027-2009 | Stryker Sternum Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI... | Stryker Corp. | KIJ | ||
| Z-1026-2009 | Stryker Reciprocating Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo... | Stryker Corp. | KIJ | ||
| Z-1025-2009 | Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6. Stryker... | Stryker Corp. | KIJ | ||
| Z-1024-2009 | Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6. Stryker... | Stryker Corp. | KIJ | ||
| Z-1023-2009 | Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker... | Stryker Corp. | KIJ | ||
| Z-1022-2009 | Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker... | Stryker Corp. | KIJ | ||
| Z-1021-2009 | Stryker Cordless Driver 3 Handpiece. Stryker Instruments, Kalamazoo, MI; REF 4300... | Stryker Corp. | KIJ | ||
| Z-2262-2012 | Class II | GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope... | GE Healthcare | OXO | |
| Z-1691-2009 | GE Innova 4100-IQ, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a... | GE Healthcare | MQB | ||
| Z-1690-2009 | GE Innova 4100, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane... | GE Healthcare | MQB | ||
| Z-1689-2009 | GE Innova 3100-IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The... | GE Healthcare | MQB | ||
| Z-1688-2009 | GE Innova 3100, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The... | GE Healthcare | MQB | ||
| Z-1687-2009 | GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha... | GE Healthcare | MQB | ||
| Z-0914-2010 | Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0603-2009 | Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to... | Hill-Rom Manufacturing, Inc. | FNM | ||
| Z-0602-2009 | Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number... | Hill-Rom Manufacturing, Inc. | FNM | ||
| Z-0601-2009 | Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607. Designed to provide... | Hill-Rom Manufacturing, Inc. | FNM | ||
| Z-0600-2009 | Synergy Pulse, Powered Flotation Therapy bed, Model number 5609. Designed to provide... | Hill-Rom Manufacturing, Inc. | FNM | ||
| Z-0837-2009 | Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456... | Boston Scientific Corporation | ITX | ||
| Z-0284-2009 | ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA | Medtronic, Inc. | FMI | ||
| Z-1014-2012 | West Nile Virus IgM Capture ELISA The Panbio West Nile Virus IgM Capture ELISA is for... | Inverness Medical, Inc. | NOP | ||
| Z-0486-2009 | FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting... | FHC, Inc. | HAW | ||
| Z-1008-2009 | Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide... | Remel Inc | JWX | ||
| Z-0627-2009 | Excelsior SL-10 Microcatheter, placed in sterile pouch. Manufactured by Boston... | Boston Scientific Corporation | DQY |