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-0037-2008 | Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the... | Medtronic Neuromodulation | EZW | ||
| Z-0718-2008 | Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24). Product Code: 866.2500; Part... | Hamilton Co | JTC | ||
| Z-1605-2009 | DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa... | Sybaritic, Inc. | IMB | ||
| Z-1604-2009 | DERMALIFE Spa-Oceana 2G System. Part #E30008-01 - Spa-Oceana 2G; Assay. This is the Spa... | Sybaritic, Inc. | IMB | ||
| Z-1603-2009 | DERMALIFE Spa Feng Shui 2G. Part #E30007-100 is: Spa-Feng Shui 2G;100V 50/60Hz. This... | Sybaritic, Inc. | IMB | ||
| Z-1602-2009 | DERMALIFE Spa Jet 2G System. Part #E30006-01 - Spa Jet 2G; Assay w/Pedestal. This is... | Sybaritic, Inc. | IMB | ||
| Z-0038-2008 | Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic... | Radiometer America, Inc | CHL | ||
| Z-0007-2008 | 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of... | Tosoh Bioscience Inc | JJX | ||
| Z-1241-2008 | Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab... | AGFA Healthcare Corp. | LLZ | ||
| Z-1226-2007 | ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for... | Becton Dickinson & Co | FMI | ||
| Z-1114-2007 | Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FRN | ||
| Z-1113-2007 | Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FRN | ||
| Z-1142-2007 | The Companion ClearStar Pump System, for enteral feeding. | Ross Products Division Abbott Laboratories | LZH | ||
| Z-1141-2007 | Embrace Enteral Pump | Ross Products Division Abbott Laboratories | LZH | ||
| Z-1112-2007 | Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare... | Baxter Healthcare Corporation | FRN | ||
| Z-1111-2007 | Baxter Flo-Gard 6201, SIngle Channel , Volumetric Infusion Pump; Baxter Healthcare... | Baxter Healthcare Corporation | FRN | ||
| Z-1149-2007 | VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and... | PROTEOR USA, Gunnison | ISH | ||
| Z-1091-2007 | Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FRN | ||
| Z-1173-2007 | ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer... | Sendx Medical, Inc. | CHL | ||
| Z-1085-2007 | Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | GDF | ||
| Z-1084-2007 | Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | GDF | ||
| Z-1083-2007 | Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | GDF | ||
| Z-1082-2007 | Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | GDF | ||
| Z-1081-2007 | Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalgo ref... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | GDF | ||
| Z-1080-2007 | Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | GDF | ||
| Z-1131-2007 | Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with Ethylene... | Possis Medical, Inc. | DXE | ||
| Z-1127-2007 | Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood... | Instrumentation Laboratory Co. | GKP | ||
| Z-0131-2008 | American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number... | American Medical Systems Innovation Center - Silicon Valley | GEX | ||
| Z-1215-2007 | Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper... | Abbott Medical | FPA | ||
| Z-1214-2007 | Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper... | Abbott Medical | FPA | ||
| Z-1213-2007 | Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented... | Abbott Medical | FPA | ||
| Z-1020-2007 | All IV Administration Infusion Sets intended for use with the Gemini Infusion Pump and... | CareFusion 303, Inc | FRN | ||
| Z-1206-2007 | Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number... | Spectrum Designs, Inc. | LZK | ||
| Z-0122-2008 | Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN... | Boston Scientific Corporation | DQX | ||
| Z-1151-2007 | Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular... | Zimmer GmbH | LXH | ||
| Z-0287-2008 | Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide... | Ellex USA | HQF | ||
| Z-0286-2008 | Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82... | Ellex USA | HQF | ||
| Z-1148-2007 | biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4... | Physio Control, Inc. | MKT | ||
| Z-1118-2007 | Liko Universal Sling Bar 450 R2R Product NUmber: 3156095 | Liko, Inc. | FRW | ||
| Z-1117-2007 | Liko Universal Sling Bar 450 Quick Release Hook (QRH) Product Number: 3156085 | Liko, Inc. | FRW | ||
| Z-1162-2007 | Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal... | Cook Incorporated | EZB | ||
| Z-0852-2007 | GE OEC 2800 mobile Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. | GE Healthcare | JAA | ||
| Z-0851-2007 | GE OEC 6800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. | GE Healthcare | JAA | ||
| Z-0850-2007 | GE OEC 8800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah | GE Healthcare | JAA | ||
| Z-0849-2007 | GE OEC 9800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. | GE Healthcare | JAA | ||
| Z-0848-2007 | GE OEC 9900 Elite Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. | GE Healthcare | JAA | ||
| Z-1128-2007 | Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A | Philips North America LLC | MKJ | ||
| Z-0994-2007 | Vortech Graft Preparation System, sterile, single use, disposable, Distributed by Biomet... | Zimmer GmbH | FMF | ||
| Z-0993-2007 | Graft Preparation System, sterile, single use, disposable, Distributed by Biomet... | Zimmer GmbH | FMF | ||
| Z-1022-2007 | Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and... | Bausch & Lomb Incorporated | HNO |