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-1918-2018 | Class II | Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The... | LivaNova USA, Inc. | DTZ | |
| Z-1485-2018 | Class II | Genesis Surgical Cassette Tapered Implants are intended for placement following natural... | Keystone Dental Inc. | DZE | |
| Z-1641-2018 | Class II | Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL... | Medtronic Sofamor Danek USA Inc | MJO | |
| Z-1479-2018 | Class II | Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code... | Medtronic, Inc. | DQO | |
| Z-2968-2018 | Class II | McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring... | Change Healthcare Israel Ltd. | DQK | |
| Z-2410-2018 | Class II | Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The... | Ohio Medical LLC | KDP | |
| Z-1878-2018 | Class II | Trident Endoscopic Ultrasonic Aspiration Needle (FNA) | Micro-Tech (Nanjing) Co., Ltd. | ODG | |
| Z-1877-2018 | Class II | Trident Endoscopic Ultrasonic Biopsy Needle (FNB) | Micro-Tech (Nanjing) Co., Ltd. | ODG | |
| Z-1879-2018 | Class II | Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151 | CooperSurgical, Inc. | HGI | |
| Z-1584-2018 | Class II | 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model... | CooperSurgical, Inc. | DRC | |
| Z-1526-2018 | Class II | Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures... | Stryker Corp. | KTT | |
| Z-1800-2018 | Class III | Syva EMIT II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440 | Siemens Healthcare Diagnostics Inc. | DJG | |
| Z-1799-2018 | Class III | Syva EMIT II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483 | Siemens Healthcare Diagnostics Inc. | DJG | |
| Z-1389-2018 | Class II | Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI... | Stryker Medical | FPO | |
| Z-1444-2018 | Class II | Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ... | TMJ Solutions, LLC | LZD | |
| Z-1236-2018 | Class II | Phoenix Nail System, intended for use with an intramedullary nail system for alignment... | Zimmer GmbH | HSB | |
| Z-1372-2018 | Class II | Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and... | Hamilton Medical AG | CBK | |
| Z-1371-2018 | Class II | Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and... | Hamilton Medical AG | CBK | |
| Z-1868-2018 | Class II | RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic... | Richard Wolf GmbH | HIF | |
| Z-2796-2018 | Class II | Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to... | Hamilton Medical AG | CBK | |
| Z-2795-2018 | Class II | Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to... | Hamilton Medical AG | CBK | |
| Z-1599-2018 | Class II | 6381 M-1 Cot Fastener, catalog no. 6381000000 | Stryker Medical | FPO | |
| Z-1598-2018 | Class II | 6376 M-1 Cot Fastener, catalog no. 6376000000 | Stryker Medical | FPO | |
| Z-1170-2018 | Class II | Proclaim DRG Implantable Pulse Generator, Model Number 3664 | Abbott Medical | PMP | |
| Z-1301-2018 | Class II | Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm... | The Binding Site Group Ltd. | JZG | |
| Z-1386-2018 | Class II | SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for... | Southern Implants, (Pty.) Ltd. | NHA | |
| Z-3041-2018 | Class II | Vascular Solutions Venture Rx Catheter, 6F, resterilized. | SPS Sterilization, Inc | DQY | |
| Z-3040-2018 | Class II | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM... | SPS Sterilization, Inc | JCT | |
| Z-3039-2018 | Class II | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary... | SPS Sterilization, Inc | JCT | |
| Z-3038-2018 | Class II | Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM... | SPS Sterilization, Inc | MQR | |
| Z-3037-2018 | Class II | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X... | SPS Sterilization, Inc | JCT | |
| Z-3036-2018 | Class II | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X... | SPS Sterilization, Inc | JCT | |
| Z-3035-2018 | Class II | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary... | SPS Sterilization, Inc | JCT | |
| Z-3034-2018 | Class II | Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized. | SPS Sterilization, Inc | DQR | |
| Z-3033-2018 | Class II | Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized. | SPS Sterilization, Inc | DWF | |
| Z-3032-2018 | Class II | Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized. | SPS Sterilization, Inc | DWF | |
| Z-3031-2018 | Class II | Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM... | SPS Sterilization, Inc | DWF | |
| Z-3030-2018 | Class II | Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM... | SPS Sterilization, Inc | DWF | |
| Z-3029-2018 | Class II | Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM... | SPS Sterilization, Inc | DWF | |
| Z-3028-2018 | Class II | Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. | SPS Sterilization, Inc | DWF | |
| Z-3027-2018 | Class II | Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. | SPS Sterilization, Inc | DWF | |
| Z-2341-2018 | Class II | da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical... | Intuitive Surgical, Inc. | NAY | |
| Z-1534-2018 | Class II | Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory... | Ethicon, Inc | FMF | |
| Z-1420-2018 | Class II | Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG... | Autochair | FSA | |
| Z-1317-2018 | Class II | D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the... | Smith & Nephew, Inc. | HWC | |
| Z-1630-2018 | Class II | Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound... | Integra LifeSciences Corporation | FRO | |
| Z-2099-2018 | Class II | ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker | Tosoh Bioscience Inc | NDY | |
| Z-2098-2018 | Class II | ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker | Tosoh Bioscience Inc | JZG | |
| Z-2097-2018 | Class II | ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy | Tosoh Bioscience Inc | DGC | |
| Z-2096-2018 | Class II | ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia | Tosoh Bioscience Inc | DBF |