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-2481-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2480-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2479-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2478-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2477-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2476-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2475-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2474-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2473-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2472-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2471-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2470-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2469-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2646-2011 | Smith & Nephew Hip Arthroscopy Repair Instrument Tray Part Number: 72202732 Device... | Smith & Nephew, Inc. | KCT | ||
| Z-2747-2011 | Quinton BETA-CAP Adapter; a Peritoneal Dialysis accessory to the PD catheter used to... | Baxter Healthcare Renal Div | FKX | ||
| Z-0201-2012 | Spirit MB Brackets, part #494-1211. The brand name of the device is Spirit MB Brackets... | Ormco/Sybronendo | DYW | ||
| Z-0200-2012 | Spirit MB Brackets, part #494-1210. The brand name of the device is Spirit MB Brackets... | Ormco/Sybronendo | DYW | ||
| Z-2764-2011 | Clinac Linear Accelerator; Model numbers H14, H27 and H29. Product Usage: Varian High... | Varian Medical Systems, Inc. | IYE | ||
| Z-2570-2011 | ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS... | Roche Diagnostics GmbH | NBW | ||
| Z-2553-2011 | Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact... | Medela AG | HFS | ||
| Z-2763-2011 | ARIA, versions 8.0 and 8.1; Varian Medical Systems, Palo Alto, CA. Product Usage: Aria... | Varian Medical Systems, Inc. | IYE | ||
| Z-2623-2011 | Baxter Interlink System Large Bore 4-Way Stopcock, Volume 0.65 mL, Injection Site... | Baxter Healthcare Corporation | FMG | ||
| Z-1616-2013 | Class II | GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging... | GE Healthcare | OWB | |
| Z-0202-2012 | Medtronic MiniMed paradigm mio Infusion Sets MMT-921 The Paradigm mio infusion sets are... | Medtronic, Inc. | FPA | ||
| Z-2918-2011 | Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring... | Welch Allyn Protocol, Inc. | DSI | ||
| Z-2717-2011 | iView DAB Detection Kit, Part number: 760-091 (05266157001) This detection kit is... | Ventana Medical Systems Inc | MYA | ||
| Z-2716-2011 | ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) This detection... | Ventana Medical Systems Inc | MYA | ||
| Z-2556-2011 | 804159, Terumo Coronary Ostia cannula, 14 Fr, 10 (25 cm) long A cardiopulmonary bypass... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-2555-2011 | 804117, Terumo Coronary Ostia cannula, 12 Fr, 10 (25 cm) long A cardiopulmonary bypass... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-2554-2011 | 804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long A cardiopulmonary bypass... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-2982-2011 | Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per... | North Coast Medi-Tek | LOR | ||
| Z-0831-2012 | Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.*... | Gulf Fiberoptics, Inc. | FST | ||
| Z-2778-2011 | Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive... | Varian Medical Systems, Inc. | IYE | ||
| Z-2780-2011 | Eclipse Treatment Planning System; Release 6.5 through 10 (build 7.3.10 through... | Varian Medical Systems, Inc. | MUJ | ||
| Z-0630-2013 | Class II | DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The... | Datascope Corp. | MSX | |
| Z-2795-2011 | XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019... | Vitrolife Inc. | MSB | ||
| Z-2573-2011 | The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer... | GE Healthcare | MHX | ||
| Z-0049-2012 | ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus... | ArthroCare Corporation | HWC | ||
| Z-2677-2011 | Remel Spectra MRSA, Ref R01821, 10 plates per package, and Ref R01822, 100 plates per... | Remel Inc | JSO | ||
| Z-2673-2011 | Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM... | Instrumentation Laboratory Co. | CHL | ||
| Z-2625-2011 | 12-lead ECG Cable Assembly contains the following cable and attachments: Main Cable with... | Physio Control, Inc. | MKJ | ||
| Z-2953-2011 | Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine... | Accriva Diagnostics, Inc. | JPA | ||
| Z-0935-2013 | Class II | Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa... | GE Healthcare | LNH | |
| Z-0984-2012 | VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical... | Ortho-Clinical Diagnostics, Inc. | LEG | ||
| Z-2954-2011 | IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation... | Accriva Diagnostics, Inc. | JPA | ||
| Z-2931-2011 | Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor... | Boston Scientific Corporation | FTL | ||
| Z-2606-2011 | Access Immunoassay Systems Quality Control Kits, Part Number: 37309 The Access Ostase QC... | Siemens Healthcare Diagnostics Inc. | JJX | ||
| Z-2605-2011 | Access Immunoassay Systems Ostase Calibrators, Part Number: 37305 The Access Ostase... | Siemens Healthcare Diagnostics Inc. | JIS | ||
| Z-2762-2011 | syngo Dynamics Picture Archiving Communication System The software is a picture... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0004-2012 | Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51... | Abbott Medical | MEA |