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-0793-2012 | Mevatron M2 6300; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0792-2012 | Mevatron KD2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0791-2012 | Mevatron ME; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0790-2012 | Mevatron KD; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0789-2012 | Mevatron MD (MD, MDX); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0788-2012 | Mevatron M 6730/6740; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0787-2012 | Mevatron M 6300 (MX); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0786-2012 | Mevatron M 6700 (MX); Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0785-2012 | Mevatron 67; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0784-2012 | Mevatron M 7400/7440 (MXE); Siemens Healthcare Concord, CA 94520 Product Usage... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0783-2012 | Mevatron 77; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0782-2012 | PRIMUS HI; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0781-2012 | Mevatron K2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0780-2012 | Mevatron M2/PRIMUS Mid; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1067-2013 | Class II | TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce... | Canon Medical Systems USA, Inc. | JAK | |
| Z-0757-2013 | Class II | Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part... | Abbott Vascular | NTE | |
| Z-0862-2012 | Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable... | Stryker Corp. | JDZ | ||
| Z-0465-2012 | CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size... | Medtronic Sofamor Danek USA Inc | KWQ | ||
| Z-0464-2012 | CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size... | Medtronic Sofamor Danek USA Inc | KWQ | ||
| Z-1318-2012 | Anesthesia Machines (digital display assembly); A gas machine for anesthesia is a... | Penlon, Ltd. | BSZ | ||
| Z-1094-2012 | ORIGIO MIDATLANTIC DEVICES CRYOPETTE (r) Rx only Single use only CRY-PETTE-CL LOT 123456... | CooperSurgical, Inc. | MQK | ||
| Z-1051-2012 | "***REF NL86004-01***INTEGRA NEUROSCIENCES***Step Down Connector***Non Sterile for Single... | Integra NeuroSciences | JXG | ||
| Z-1050-2012 | "***REF NL82059-03***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use... | Integra NeuroSciences | JXG | ||
| Z-1049-2012 | "***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use... | Integra NeuroSciences | JXG | ||
| Z-1048-2012 | "***REF NL82059-01***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use... | Integra NeuroSciences | JXG | ||
| Z-0692-2012 | Varian High Energy Linear Accelerator, C-Series Clinac, Reference/FSCA Identifier... | Varian Medical Systems, Inc. | IYE | ||
| Z-0483-2012 | Varian Unique Single Energy Linear Accelerator, C-Series Clinac or Trilogy, versions 7.x... | Varian Medical Systems, Inc. | IYE | ||
| Z-0671-2012 | Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck... | Abbott Medical | BTO | ||
| Z-0670-2012 | Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange) | Abbott Medical | BTO | ||
| Z-0669-2012 | Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck... | Abbott Medical | BTO | ||
| Z-0668-2012 | Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck... | Abbott Medical | BTO | ||
| Z-0667-2012 | Bivona TTS Cuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck... | Abbott Medical | BTO | ||
| Z-0666-2012 | Bivona TTS Cuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck... | Abbott Medical | BTO | ||
| Z-0665-2012 | Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0... | Abbott Medical | BTO | ||
| Z-0664-2012 | Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0... | Abbott Medical | BTO | ||
| Z-0663-2012 | Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With... | Abbott Medical | BTO | ||
| Z-0662-2012 | Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With... | Abbott Medical | BTO | ||
| Z-0661-2012 | Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a... | Abbott Medical | BTO | ||
| Z-0660-2012 | Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a... | Abbott Medical | BTO | ||
| Z-0659-2012 | Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 Product Usage: This tube is... | Abbott Medical | BTO | ||
| Z-0658-2012 | Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 Product Usage: This tube is... | Abbott Medical | BTO | ||
| Z-0657-2012 | Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck... | Abbott Medical | BTO | ||
| Z-0656-2012 | Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck... | Abbott Medical | BTO | ||
| Z-1047-201 | "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non... | Integra NeuroSciences | JXG | ||
| Z-0458-2012 | St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models... | Abbott Medical | LWS | ||
| Z-0457-2012 | St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581... | Abbott Medical | LWS | ||
| Z-0747-2012 | Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in... | OLYMPUS Corporation of the Americas | GEI | ||
| Z-0485-2012 | Raymond Laser alignment guide - Model #1096597/002 Red Laser. Intended to assist... | The Raymond Corporation | RER | ||
| Z-0484-2012 | Raymond Laser alignment guide - Model #1096597/001 Green Laser. Intended to assist... | The Raymond Corporation | RER | ||
| Z-0516-2012 | Portal Vision, R-Arm with 4D Integrated Treatment Console; Varian Medical Systems. Palo... | Varian Medical Systems, Inc. | IYE |