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-1656-2009 | Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED... | Welch Allyn Protocol, Inc. | MKJ | ||
| Z-1931-2009 | iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System... | Abiomed, Inc. | DSQ | ||
| Z-1624-2009 | ConforMIS iUni ( Unicondylar Knee System iUni Right Lateral Implant Kit Product Code... | ConforMIS, Inc. | HSX | ||
| Z-1623-2009 | ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code... | ConforMIS, Inc. | HSX | ||
| Z-1622-2009 | ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code... | ConforMIS, Inc. | HSX | ||
| Z-1411-2009 | SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the... | Respironics, Inc. | FLS | ||
| Z-1813-2009 | Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery... | Respironics, Inc. | CBK | ||
| Z-1677-2009 | Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-1676-2009 | Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-2001-2009 | Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781... | Roche Diagnostics GmbH | DKB | ||
| Z-2000-2009 | Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790... | Roche Diagnostics GmbH | DKB | ||
| Z-2328-2009 | Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery... | Abbott Medical | CGA | ||
| Z-2016-2009 | HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part... | Hach Company | LIF | ||
| Z-1083-2010 | OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical... | Opti Medical Systems Inc | CGZ | ||
| Z-2012-2009 | Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot... | Johnson & Johnson Vision Care, Inc. | LPL | ||
| Z-2275-2009 | Posey Swedish Belt (1337). Intended for medical purposes to limit a patient's movement... | J. T. Posey Co. | FMQ | ||
| Z-2274-2009 | Special Order, Posey Connected Twice-As-Tough Cuffs, Ankle (for use on the bed)... | J. T. Posey Co. | FMQ | ||
| Z-2273-2009 | Special Order, Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed)... | J. T. Posey Co. | FMQ | ||
| Z-2272-2009 | Posey Locking Twice-As Tough Ambulatory Belt (2800). Intended for medical purposes to... | J. T. Posey Co. | FMQ | ||
| Z-2271-2009 | Posey Locking Twice-As Tough Cuffs, Ankles (lock on cuff and strap) (2799). Intended... | J. T. Posey Co. | FMQ | ||
| Z-2270-2009 | Posey Locking Twice-As Tough Cuffs, Wrists (lock on cuff & strap) (2798). Intended for... | J. T. Posey Co. | FMQ | ||
| Z-2269-2009 | Posey Connected Twice-As Tough Cuffs, Ankles (for use on bed) (2795). Intended for... | J. T. Posey Co. | FMQ | ||
| Z-2268-2009 | Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (2794). Intended for... | J. T. Posey Co. | FMQ | ||
| Z-2267-2009 | Posey Locking Twice-As Tough Cuffs, Ankles (lock on strap) (2793). Intended for... | J. T. Posey Co. | FMQ | ||
| Z-2266-2009 | Posey Locking Twice-As Tough Cuffs, Wrists (lock on strap) (2792). Intended for... | J. T. Posey Co. | FMQ | ||
| Z-2265-2009 | Posey Connecting Strap/Belt, Polypropylene, 72" (235072). Intended for medical... | J. T. Posey Co. | FMQ | ||
| Z-2264-2009 | Posey Connecting Strap/Belt, Polypropylene, 60" (235060). Intended for medical... | J. T. Posey Co. | FMQ | ||
| Z-2263-2009 | Posey Connecting Strap/Belt, Polypropylene, 48" (235048). Intended for medical... | J. T. Posey Co. | FMQ | ||
| Z-2262-2009 | Posey Connecting Strap/Belt, Polypropylene, 36" (235036). Intended for medical... | J. T. Posey Co. | FMQ | ||
| Z-2261-2009 | Posey Connecting Strap/Belt, Polypropylene, 24" (235024). Intended for medical... | J. T. Posey Co. | FMQ | ||
| Z-2260-2009 | Posey Connecting Strap/Belt, Polypropylene, 18" (235018). Intended for medical... | J. T. Posey Co. | FMQ | ||
| Z-2259-2009 | Posey Connecting Strap/Belt, Cotton, 72" (232072). Intended for medical purposes to... | J. T. Posey Co. | FMQ | ||
| Z-2258-2009 | Posey Connecting Strap/Belt, Cotton, 60" (232060). Intended for medical purposes to... | J. T. Posey Co. | FMQ | ||
| Z-2257-2009 | Posey Connecting Strap/Belt, Cotton, 48" (232048). Intended for medical purposes to... | J. T. Posey Co. | FMQ | ||
| Z-2256-2009 | Posey Connecting Strap/Belt, Cotton, 36" (232036). Intended for medical purposes to... | J. T. Posey Co. | FMQ | ||
| Z-2255-2009 | Posey Fifth Point Restraint, Locking (2219L). Intended for medical purposes to limit a... | J. T. Posey Co. | FMQ | ||
| Z-2254-2009 | Posey Key Lock Belt (1334). Intended for medical purposes to limit a patient's... | J. T. Posey Co. | FMQ | ||
| Z-0338-2010 | Hill-Rom 100 Low Bed, Model P3930. AC-powered adjustable hospital bed. | Hill-Rom Inc. | FNL | ||
| Z-1266-2013 | Class III | Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1265-2013 | Class III | Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1264-2013 | Class III | Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1263-2013 | Class III | Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1262-2013 | Class III | Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1261-2013 | Class III | Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1260-2013 | Class III | Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1259-2013 | Class III | Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1258-2013 | Class III | Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1257-2013 | Class III | Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1256-2013 | Class III | Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1255-2013 | Class III | Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to... | Spinal Elements, Inc | NKB |