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-1557-2008 | Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000... | Arjo, Inc. | FSA | ||
| Z-2309-2008 | ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The... | ArthroCare Corporation | GEI | ||
| Z-0298-2009 | "LOCATOR Abutment for 5.7 Screw-Vent & Compatibles." Zest Anchors, Inc. Product is sold... | Zest Anchors LLC | DZE | ||
| Z-1816-2008 | ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF... | Medtronic, Inc. | NIP | ||
| Z-2056-2008 | CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment... | Accuray Incorporated | IYE | ||
| Z-2577-2011 | XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00 Used to... | Elekta Limited | MUJ | ||
| Z-1575-2009 | Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20... | Centurion Medical Products, LP | OKE | ||
| Z-1574-2009 | Tri-State Hospital Supply Corp., Tri-State Centurion Port Blood Draw Trays, Qty/case 20... | Centurion Medical Products, LP | OKE | ||
| Z-1573-2009 | Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20... | Centurion Medical Products, LP | OKE | ||
| Z-1572-2009 | Tri-State Hospital Supply Corporation, Tri-State Centurion CVC (Central Venous Catheter)... | Centurion Medical Products, LP | OFF | ||
| Z-1571-2009 | Tri-State Hospital Supply Corp., Tri-State Centurion Venous Access Port Kits, Qty/case... | Centurion Medical Products, LP | OKE | ||
| Z-1731-2009 | Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the... | Siemens Healthcare Diagnostics Inc. | MMI | ||
| Z-1807-2008 | Fluid Administration Set, Custom Kit, REF: K10-01795DP, Caution: For manufacturing... | Merit Medical Systems, Inc. | FPA | ||
| Z-1806-2008 | Fluid Administration Set, Custom Kit, REF: K09-01280JP, Caution: For manufacturing... | Merit Medical Systems, Inc. | FPA | ||
| Z-1805-2008 | Fluid Administration Set, Custom Kit, REF: K09-09051P, Caution: For manufacturing... | Merit Medical Systems, Inc. | FPA | ||
| Z-1804-2008 | Fluid Administration Set, Custom Kit, REF: K09-09938P, Caution: For manufacturing... | Merit Medical Systems, Inc. | FPA | ||
| Z-1803-2008 | Fluid Administration Set, Custom Kit, REF: K09-02842CP, Caution: For manufacturing... | Merit Medical Systems, Inc. | FPA | ||
| Z-1802-2008 | Fluid Administration Set, Custom Kit, REF: K09-05971AP, Caution: For manufacturing... | Merit Medical Systems, Inc. | FPA | ||
| Z-1801-2008 | Fluid Administration Set, Custom Kit, REF: K09-05785FP, Caution: For manufacturing... | Merit Medical Systems, Inc. | FPA | ||
| Z-1800-2008 | Fluid Administration Set, Custom Kit, REF: K09-05336DP, Caution: For manufacturing... | Merit Medical Systems, Inc. | FPA | ||
| Z-1895-2008 | Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and... | Philips North America LLC | KPR | ||
| Z-1603-2008 | Hill-Rom 100 Low Bed; Model No. P3930. | Hill-Rom Inc. | FNL | ||
| Z-1694-2008 | The OptiVantage DH Injection System is a contrast delivery system and is designed to... | Mallinckrodt, Inc. | IZQ | ||
| Z-1715-2008 | In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human... | Siemens Healthcare Diagnostics Inc. | JHI | ||
| Z-2387-2008 | UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2386-2008 | Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System | Siemens Healthcare Diagnostics Inc. | CFR | ||
| Z-2385-2008 | SYNCHRON LXi 725 System | Siemens Healthcare Diagnostics Inc. | JGS | ||
| Z-2384-2008 | Access and Access 2 Immunoassay System | Siemens Healthcare Diagnostics Inc. | CGN | ||
| Z-1555-2008 | Zimmer Dermacarriers Skin Graft Carriers, S.G. Carrier 16IN length, Rx, latex free... | Zimmer GmbH | FZW | ||
| Z-1554-2008 | Zimmer Dermacarriers skin graft carriers, S.G. Carrier 8IN length, Rx, latex free... | Zimmer GmbH | FZW | ||
| Z-1553-2008 | Zimmer Dermacarriers II skin graft carriers, 9 to 1 dermacarrier, Rx, latex free... | Zimmer GmbH | FZW | ||
| Z-1552-2008 | Zimmer Dermacarriers II skin graft carriers, 6 to 1 dermacarrier, Rx, latex free... | Zimmer GmbH | FZW | ||
| Z-1551-2008 | Zimmer Dermacarriers II skin graft carriers, 3 to 1 dermacarrier, Rx, latex free... | Zimmer GmbH | FZW | ||
| Z-1550-2008 | Zimmer Dermacarriers II skin graft carriers, 1.5 to 1 dermacarrier, Rx, latex free... | Zimmer GmbH | FZW | ||
| Z-1655-2008 | Hill-Rom Procedural Stretcher with auto-contour option; Model P8000F. Wheeled hospital... | Hill-Rom Inc. | FPO | ||
| Z-0285-2009 | GE Healthcare Solar 8000M System, a multiparameter physiological patient monitoring... | GE Healthcare | DSI | ||
| Z-2105-2008 | Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile... | Boston Scientific Corporation | FGE | ||
| Z-1815-2008 | ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot... | Medtronic, Inc. | NIP | ||
| Z-1702-2008 | Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System... | Advanced Medical Optics, Inc. | HQC | ||
| Z-1649-2008 | BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004, | Abbott Medical | DXN | ||
| Z-2467-2008 | OPHIT Optical Digital Visual Interface (DVI) Extender, Part number 0100224051, a... | STRYKER Communications, Inc. | GCJ | ||
| Z-2404-2008 | GE Voluson E8 Ultrasound System with software versions 6.0.0, 6.0.1,6.1.0, 6.2.0, 6.2.1... | GE Healthcare | IYO | ||
| Z-1908-2008 | Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-IK, Lot number... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LDF | ||
| Z-1907-2008 | Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot number... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LDF | ||
| Z-1773-2008 | Infusion System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug... | EKOS Corporation | KRA | ||
| Z-2572-2011 | Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02. For use... | Elekta Limited | MUJ | ||
| Z-1917-2008 | Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood... | Celsus Laboratories Inc | JKA | ||
| Z-1772-2008 | Bariatric Wheelchair, 28" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured... | MEDLINE INDUSTRIES, LP - Northfield | IOR | ||
| Z-1771-2008 | Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured... | MEDLINE INDUSTRIES, LP - Northfield | IOR | ||
| Z-1770-2008 | Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured... | MEDLINE INDUSTRIES, LP - Northfield | IOR |