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-2208-2009 | Boston Scientific HydroThermAblator Endometrial Ablation System- HTA Procedure Set... | Boston Scientific Corporation | MNB | ||
| Z-2242-2009 | Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 (The... | GE Healthcare | MQB | ||
| Z-2241-2009 | Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE... | GE Healthcare | MQB | ||
| Z-2240-2009 | GE, Innova 2000 The principle system components include a C-arm, image acquisition... | GE Healthcare | MQB | ||
| Z-1679-2013 | Class II | Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices... | Baxter Healthcare Corporation | MEB | |
| Z-1678-2013 | Class II | Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices... | Baxter Healthcare Corporation | MEB | |
| Z-1677-2013 | Class II | Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices... | Baxter Healthcare Corporation | MEB | |
| Z-2065-2011 | Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-1802-2010 | Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a... | Medtronic, Inc. | FGE | ||
| Z-1064-2011 | Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1948-2009 | BARD Simpulse" SOLO System with Soft Splash Shield Tip Product Code: 0067590. The... | Davol Inc., Sub. C.R. Bard, Inc. | FHQ | ||
| Z-0457-2010 | GE Medical Systems, COMPAX 40E X-ray Systems, Models; 2208203, 2208205, 2244282... | GE Healthcare | IZZ | ||
| Z-1014-2010 | Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI... | Horiba Instruments Incorporated | CIG | ||
| Z-1693-2009 | Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA... | Draeger Medical Systems, Inc. | FMT | ||
| Z-2045-2009 | Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative... | ConvaTec Limited | OMP | ||
| Z-2044-2009 | Engenex Cover Strip; Product Code 446471; Advanced Negative Wound Therapy... | ConvaTec Limited | OMP | ||
| Z-2043-2009 | Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound Therapy... | ConvaTec Limited | OMP | ||
| Z-1905-2010 | Unicel DxH 800 Coulter Cellular Analysis System, Part number(s): 629029 | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1873-2009 | Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). The VSM300 can monitor... | Welch Allyn Protocol, Inc. | MWI | ||
| Z-1603-2010 | Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by... | Stryker Corp. | HST | ||
| Z-1404-2010 | Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA | Novasys Medical, Inc. | NVJ | ||
| Z-1954-2009 | Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter... | Medtronic, Inc. | LWS | ||
| Z-1953-2009 | Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implantable cardioverter defibrillator... | Medtronic, Inc. | LWS | ||
| Z-0536-2010 | Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200. Distributed by Medtronic... | Medtronic Xomed, Inc. | LRK | ||
| Z-0535-2010 | Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. Distributed by... | Medtronic Xomed, Inc. | LRK | ||
| Z-0264-2010 | Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version... | LivaNova USA, Inc. | LYJ | ||
| Z-2061-2011 | Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01... | Siemens Medical Solutions USA, Inc. | IYO | ||
| Z-2147-2011 | Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers... | Siemens Medical Solutions USA, Inc. | IYO | ||
| Z-2253-2009 | VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is... | Spryson America Inc | LXV | ||
| Z-2009-2009 | Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator... | Mission Systems Davenport Inc. | CAW | ||
| Z-1910-2009 | Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for... | Wilson-Cook Medical Inc. | KNT | ||
| Z-2633-2011 | Tubing Assembly #142, V2, V12 Mixer/Wash a component of the DxC instruments. Tube... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2211-2009 | Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided... | GE Healthcare | MHX | ||
| Z-2384-2011 | Newport HT50 Ventilator, Model # HT-50-H, HT50-HB, HT50-H1, and HT50-H1B Product Code... | Newport Medical Instruments, Inc. | CBK | ||
| Z-2004-2009 | Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis... | Roche Diagnostics GmbH | GJS | ||
| Z-2003-2009 | Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN... | Roche Diagnostics GmbH | GJS | ||
| Z-2002-2009 | Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics... | Roche Diagnostics GmbH | GJS | ||
| Z-0853-2011 | RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife... | Accuray Incorporated | JAI | ||
| Z-0364-2010 | Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0363-2010 | Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Lt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0362-2010 | Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Lt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0361-2010 | Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0360-2010 | Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0359-2010 | Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0358-2010 | Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0357-2010 | Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0356-2010 | Orthopediatrics IM Femoral Nail - 7mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0355-2010 | Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0354-2010 | Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB | ||
| Z-0353-2010 | Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Lt, non-sterile, Orthopediatrics, Warsaw... | Orthopediatrics Corp | HSB |