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-1244-2010 | Powerheart 9300E automated external defibrillator. This semi-automatic model requires... | ZOLL Medical Corporation | MKJ | ||
| Z-1243-2010 | Powerheart 9300A automated external defibrillator. This fully automatic model does not... | ZOLL Medical Corporation | MKJ | ||
| Z-1144-2010 | Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps... | Blackstone Medical, Inc. | MNI | ||
| Z-1975-2011 | Rapid Response HUT (Head Up Tilt) Table. Model 1217. Powered electrophysiology tilt table... | Medical Positioning Inc | IXR | ||
| Z-1974-2011 | Rapid Response HUT (Head Up Tilt) Table. Model 1117. Powered electrophysiology tilt table... | Medical Positioning Inc | IXR | ||
| Z-1973-2011 | Rapid Response H.U.T. (Head Up Tilt) Table. Model 1017. Powered electrophysiology tilt... | Medical Positioning Inc | IXR | ||
| Z-0788-2011 | HiSpeed FX/I (2201000-2 with Gantry mo. #2249696-2) | GE Healthcare | JAK | ||
| Z-0787-2011 | HiSpeed FX/I (2201000-2 with Gantry mo. #2249696) | GE Healthcare | JAK | ||
| Z-0786-2011 | HiSpeed FX/I (2201000-2 with Gantry mo. #2201000-2) | GE Healthcare | JAK | ||
| Z-0785-2011 | HiSpeed FX/I (2201000-2 with Gantry mo. #2201000) | GE Healthcare | JAK | ||
| Z-0784-2011 | HiSpeed FX/I (2201000-2 with Gantry mo. #2200997-2) | GE Healthcare | JAK | ||
| Z-0783-2011 | HiSpeed FX/I (2201000-2 with Gantry mo. #2200997) | GE Healthcare | JAK | ||
| Z-0782-2011 | HiSpeed FX/I (2200997-2 with Gantry mo. #2249696-2) | GE Healthcare | JAK | ||
| Z-0781-2011 | HiSpeed FX/I (2200997-2 with Gantry mo. #2249696) | GE Healthcare | JAK | ||
| Z-0780-2011 | HiSpeed FX/I (2200997-2 with Gantry mo. #2201000-2) | GE Healthcare | JAK | ||
| Z-0779-2011 | HiSpeed FX/I (2200997-2 with Gantry mo. #2201000) | GE Healthcare | JAK | ||
| Z-0778-2011 | HiSpeed FX/I (2200997-2 with Gantry mo. #2200997-2) | GE Healthcare | JAK | ||
| Z-0777-2011 | HiSpeed FX/I (2200997-2 with Gantry mo. #2200997) | GE Healthcare | JAK | ||
| Z-0776-2011 | HiSpeed FX/I (2200997 with Gantry mo. #2249696-2) | GE Healthcare | JAK | ||
| Z-0775-2011 | HiSpeed FX/I (2200997 with Gantry mo. #2249696) | GE Healthcare | JAK | ||
| Z-0774-2011 | HiSpeed FX/I (2200997 with Gantry mo. #2201000-2) | GE Healthcare | JAK | ||
| Z-0773-2011 | HiSpeed FX/I (2200997 with Gantry mo. #2200997-2) | GE Healthcare | JAK | ||
| Z-0772-2011 | HiSpeed FX/I (2200997 with Gantry mo. #2201000) | GE Healthcare | JAK | ||
| Z-0771-2011 | HiSpeed FX/I (2200997 with Gantry mo. #2200997) | GE Healthcare | JAK | ||
| Z-0770-2011 | Hi Speed DX/I (2249696-2) | GE Healthcare | JAK | ||
| Z-0768-2011 | HiSpeed DX/I (2249696) | GE Healthcare | JAK | ||
| Z-0747-2011 | HiSpeed DX/I (2201000-2) | GE Healthcare | JAK | ||
| Z-0746-2011 | HiSpeed DX/I (2201000) | GE Healthcare | JAK | ||
| Z-0745-2011 | HiSpeed LX/l (2200997-2) | GE Healthcare | JAK | ||
| Z-0744-2011 | HiSpeed LXI (2200997) | GE Healthcare | JAK | ||
| Z-1130-2010 | Burette Set with SmartSite(TM) Y-Injection Site and SmartSite(TM) HEP-Lock on Burette... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1129-2010 | 4-Way "Hi-Flo" Extension Set with Two SmartSite(TM) Y-Injection Sites and Rotating Luer... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1128-2010 | Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1127-2010 | Positive Pressure Blood Pumps, with Pre-Pierced Y-Injection Site; with Three... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1126-2010 | 7" Non-Kink Extension Set with Rotating Luer-Lock Connector. An Intravenous... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1125-2010 | Y-Type Positive Pressure Pump Set with 2-Gang 4-Way Stopcock and Detachable 4-Way... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1124-2010 | 10 Drop IV Sets, with 3 Pre-Pierced Y-Injection Sites and 3-Gang Pressure Activated... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1123-2010 | 8" Extension Set with SmartSite(TM) HEP-Lock and Rotating Luer Lock. SmartSite(TM) is a... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1122-2010 | IV Set with Two SmartSite(TM) Y-Injection Sites, Stopcock and 3-Gang Pressure Activated... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1121-2010 | 8" Microbore Extension with Detachable SmartSite(TM) HEP-Lock and Retractable Spinning... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1120-2010 | 20 Drop IV Set with 3 SmartSite(TM) Y-Injection Sites, 2-Gang 4-Way Stopcock and Novex... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1119-2010 | 150ML Burette IV Set with SmartSite(TM) Y-Injection Site, 2-Gang Standard Bore Stopcocks... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1118-2010 | 60 Drop IV Set with SmartSite(TM) Y-Injection Sites, 2-Gang Standard Bore Stopcocks and... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-2081-2012 | Class II | The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10... | Mallinckrodt, Inc. | DXT | |
| Z-1117-2010 | Positive Pressure Blood Pump Sets, with Stopcock and Smartsite(TM) Y-Injection Site and... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1116-2010 | Non-Vented IV Set with 2-Gang "Hi-Flo" Stopcocks with Luer Activated HEP Lock Valves and... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1115-2010 | 15 Drop IV Sets, with Retractable Luer-Lock and with Smartsite(TM) Y-Injection sites and... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1114-2010 | IV Extension Set with Spike and 2-Way Stopcock. An Intravenous Administration Tubing... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1113-2010 | Y-Type Blood Pump Sets, with Detachable Polysulfone Stopcock. For Veterinary Use Only and... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1112-2010 | IV Sets and Accessories, various configurations. An Intravenous Administration Tubing... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA |