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-0901-2011 | One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by... | Cutler Campus | LSZ | ||
| Z-0717-2011 | Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager) | Siemens Medical Solutions USA, Inc. | MQB | ||
| Z-0559-2011 | Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Revision A, Merit Medical... | Merit Medical Systems, Inc. | DQO | ||
| Z-0558-2011 | Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Manufactured by Merit Medical... | Merit Medical Systems, Inc. | DQO | ||
| Z-0557-2011 | Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09815, Manufacturer: Merit Medical... | Merit Medical Systems, Inc. | DQO | ||
| Z-0556-2011 | Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision B, Manufacturer: Merit... | Merit Medical Systems, Inc. | DQO | ||
| Z-0555-2011 | Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision A, Merit Medical... | Merit Medical Systems, Inc. | DQO | ||
| Z-0554-2011 | Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09304, Revision B, Manufacturer: Merit... | Merit Medical Systems, Inc. | DQO | ||
| Z-0553-2011 | Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872P, Revision H, Manufacturer: Merit... | Merit Medical Systems, Inc. | DQO | ||
| Z-0552-2011 | Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872 Revision H, Merit Medical Systems... | Merit Medical Systems, Inc. | DQO | ||
| Z-0428-2011 | Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020... | Penumbra Inc. | NRY | ||
| Z-0475-2011 | Medtronic Sprint Quattro Secure, model 6947. Steroid eluting, quadripolar, screw-in... | Medtronic, Inc. | LWS | ||
| Z-0474-2011 | Medtronic Sprint Quattro Secure S, model 6935. Steroid eluting, tripolar, screw-in... | Medtronic, Inc. | LWS | ||
| Z-1727-2011 | Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein) "Catalog numbers... | Stryker Biotech | OJZ | ||
| Z-0072-2012 | ***REF #250***TAPSCOPE 550F. Each pouch contains one (1) 18 French esophageal stethoscope... | Cardiocommand Inc. | LPA | ||
| Z-2081-2011 | UniCel DxC 600 The UniCel DxC SynchronClinical Systems are fully automated... | Siemens Healthcare Diagnostics Inc. | CEM | ||
| Z-2080-2011 | UniCel 600 PRO The UniCel DxC SynchronClinical Systems are fully automated... | Siemens Healthcare Diagnostics Inc. | CEM | ||
| Z-2079-2011 | UniCel DxC 600i The UniCel DxC SynchronClinical Systems are fully automated... | Siemens Healthcare Diagnostics Inc. | CEM | ||
| Z-2078-2011 | UniCel DxC 800 The UniCel DxC SynchronClinical Systems are fully automated... | Siemens Healthcare Diagnostics Inc. | CEM | ||
| Z-2077-2011 | UniCel DxC 800 PRO The UniCel DxC SynchronClinical Systems are fully automated... | Siemens Healthcare Diagnostics Inc. | CEM | ||
| Z-2076-2011 | UniCel DxC 880i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or... | Siemens Healthcare Diagnostics Inc. | CEM | ||
| Z-2075-2011 | UniCel DxC 660i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or... | Siemens Healthcare Diagnostics Inc. | CEM | ||
| Z-2074-2011 | UniCel DxC 680i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or... | Siemens Healthcare Diagnostics Inc. | CEM | ||
| Z-2073-2011 | UniCel DxC860i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel... | Siemens Healthcare Diagnostics Inc. | CEM | ||
| Z-2072-2011 | Synchron LX 20 The Synchron LX Systems are fully automated, computer-controlled... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2071-2011 | Synchron LX 20 PRO The SYNCHRON LX20 PRO is a fully automated, computer-controlled... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2070-2011 | Synchron LX I 725 The Synchron LXi 725 System combines the Synchron LX20 PRO analyzer... | Siemens Healthcare Diagnostics Inc. | JGS | ||
| Z-1608-2011 | ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case... | Orthofix SRL | NKB | ||
| Z-1674-2011 | BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self... | Orthofix SRL | NKB | ||
| Z-0967-2011 | StaXx XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm... | Spine Wave Inc | |||
| Z-0506-2011 | Merit MEDALLION Syringe, 10ml, REF: MSSW11-Y, Sterile EO, Single Use, Merit Medical... | Merit Medical Systems, Inc. | FMF | ||
| Z-0505-2011 | Merit MEDALLION Syringe, 10ml, REF: MSSW11-R, Sterile EO, Single Use, Merit Medical... | Merit Medical Systems, Inc. | FMF | ||
| Z-0504-2011 | VACLOCK Syringe, 20ml, REF: VAC120E, Sterile EO, Single Use, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | FMF | ||
| Z-0503-2011 | VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc... | Merit Medical Systems, Inc. | FMF | ||
| Z-0835-2011 | Mammography Keypad Radiologists and Technologist apply hotkeys from a keyboard for ease... | AGFA Healthcare Corp. | LLZ | ||
| Z-0436-2011 | LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 55cm Tape 20 strips Catalog Number... | LeMaitre Vascular Inc. | FTY | ||
| Z-0435-2011 | LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 30cm Tape, 100 strips Catalog Number... | LeMaitre Vascular Inc. | FTY | ||
| Z-0434-2011 | LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 100 strips Catalog Number... | LeMaitre Vascular Inc. | FTY | ||
| Z-0433-2011 | LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 20 strips Catalog Number... | LeMaitre Vascular Inc. | FTY | ||
| Z-1007-2012 | Flow Tec Part Number 3786-754, Syringe Lot Number 165741 The intended use of the device... | Sybron Dental Specialties, Inc. | EBF | ||
| Z-1006-2012 | Flow Tec Part Number 3784-514, Syringe Lot Number 165741 The intended use of the device... | Sybron Dental Specialties, Inc. | EBF | ||
| Z-1000-2012 | Artiste Flowable Value Pack Part Number N28VA, Syringe Lot Number 165741 The intended... | Sybron Dental Specialties, Inc. | EBF | ||
| Z-1005-2012 | Artiste Flowable Part Number N28A, Syringe Lot Number 165741 The intended use of the... | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0887-2011 | TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer... | Zimmer GmbH | LXH | ||
| Z-0845-2011 | Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System... | Micrus Endovascular Corporation | HCG | ||
| Z-0502-2011 | Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile... | Baxter Healthcare Corporation | FPA | ||
| Z-1980-2011 | UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2128-2011 | UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2121-2011 | UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2114-2011 | UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800... | Siemens Healthcare Diagnostics Inc. | GKZ |