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-1904-2009 | ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN... | Memphis Fertility Laboratory Inc | NUC | ||
| Z-1966-2009 | Apex Hip System Bipolar Head, 22.225mm ID, 38 mm OD Product Code: H3-82238. Intended... | Omni Life Science, Inc. | KWY | ||
| Z-0465-2010 | Shower Seat, Rotating, Catalog number 727152100 | Nutech Manufacturing Corp | IKX | ||
| Z-0464-2010 | Shower Seat, Non-rotating, Catalog number 727152000 | Nutech Manufacturing Corp | IKX | ||
| Z-0463-2010 | Bath Safe Adjustable Transfer Bench, Catalog numbers 727142500, 727142501, and MDS86960R | Nutech Manufacturing Corp | IKX | ||
| Z-0462-2010 | Bath Safe Adjustable Shower Seat, With Arms and Back, Catalog numbers 727142120... | Nutech Manufacturing Corp | IKX | ||
| Z-0461-2010 | Bath Safe Adjustable Shower Seat, With Back, Catalog number 727142101 | Nutech Manufacturing Corp | IKX | ||
| Z-0460-2010 | Bath Safe Adjustable Shower Seat, With Arms, Model numbers 727142020, 727142021, and... | Nutech Manufacturing Corp | IKX | ||
| Z-0459-2010 | Bath Safe Adjustable Shower Seat, Without Back and Arms, Catalog number 727142001 | Nutech Manufacturing Corp | IKX | ||
| Z-2010-2009 | Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The... | Instrumentation Industries, Incorporated | BTO | ||
| Z-1425-2012 | Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative... | Abbott Medical | CIG | ||
| Z-1997-2009 | MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous... | 3M Imtec | KKO | ||
| Z-1811-2009 | BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA. | Becton Dickinson & Co | FMF | ||
| Z-1795-2009 | HeartStart MRx/MRxE Defibrillator/Monitor Models: M3536A (HeartStart MRx) and M3536J... | Philips North America LLC | mkj | ||
| Z-0599-2010 | Stryker MIS Bur, 3.0mm Neuro Diamond Course, sterile, Stryker Instruments, Kalamazoo, MI... | Stryker Corp. | HBE | ||
| Z-0598-2010 | Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF... | Stryker Corp. | HBE | ||
| Z-0597-2010 | Stryker MIS Bur, 3.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF... | Stryker Corp. | HBE | ||
| Z-0596-2010 | Stryker MIS Bur, 2.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF... | Stryker Corp. | HBE | ||
| Z-0595-2010 | Stryker MIS Bur, 2.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF... | Stryker Corp. | HBE | ||
| Z-0545-2010 | Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged in 8 piece shelf... | Terumo Cardiovascular Systems Corporation | KFM | ||
| Z-0544-2010 | Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf... | Terumo Cardiovascular Systems Corporation | KFM | ||
| Z-1667-2009 | Diagnost 76 | Philips North America LLC | JAA | ||
| Z-1666-2009 | Diagnost 96/97 DSI | Philips North America LLC | JAA | ||
| Z-1665-2009 | OmniDiagnost | Philips North America LLC | JAA | ||
| Z-1664-2009 | MultiDiagnost MD4 | Philips North America LLC | JAA | ||
| Z-1663-2009 | MultiDiagnost MD3 | Philips North America LLC | JAA | ||
| Z-1662-2009 | UroDiagnost | Philips North America LLC | JAA | ||
| Z-1661-2009 | LithoDiagnost | Philips North America LLC | JAA | ||
| Z-1660-2009 | Easy Diagnost Digital | Philips North America LLC | JAA | ||
| Z-1659-2009 | EasyDiagnost | Philips North America LLC | JAA | ||
| Z-1891-2009 | Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex... | Teleflex Medical | BTR | ||
| Z-1890-2009 | Sheridan Preformed Cuffed Tracheal Tube, Nasal 6.5, Catalog Number: 5-22313, Teleflex... | Teleflex Medical | BTR | ||
| Z-1877-2009 | Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For... | Boston Scientific Corporation | GEI | ||
| Z-1876-2009 | Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For... | Boston Scientific Corporation | GEI | ||
| Z-2049-2009 | Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter... | Penumbra Inc. | DQY | ||
| Z-1894-2009 | Baxter Minicap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp; six sets... | Baxter Healthcare Corporation | KDJ | ||
| Z-1892-2009 | BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems... | Philips North America LLC | KPS | ||
| Z-1712-2009 | Twin-Pass Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only... | Vascular Solutions LLC | DQY | ||
| Z-1893-2009 | Baxter Minicap Extended Life PD Transfer Set (6") with Twist Clamp; six sets per carton... | Baxter Healthcare Corporation | KDJ | ||
| Z-0388-2010 | Zimmer Natural Nail System, Connecting Knob, nonsterile, Zimmer, Warsaw, IN; REF... | Zimmer GmbH | HSB | ||
| Z-0387-2010 | Zimmer Natural Nail System, Tibial Module, nonsterile, Zimmer, Warsaw, IN; REF... | Zimmer GmbH | HSB | ||
| Z-0386-2010 | Zimmer Natural Nail System, Antegrade Femoral Recon Module, small, nonsterile, Zimmer... | Zimmer GmbH | HSB | ||
| Z-0385-2010 | Zimmer Natural Nail System, Antegrade Femoral Interlock Module, small, nonsterile... | Zimmer GmbH | HSB | ||
| Z-0384-2010 | Zimmer Natural Nail System, Antegrade Femoral interlock Module, tall, nonsterile, Zimmer... | Zimmer GmbH | HSB | ||
| Z-0383-2010 | Zimmer Natural Nail System, Antegrade Femoral Recon Module, standard, nonsterile, Zimmer... | Zimmer GmbH | HSB | ||
| Z-0382-2010 | Zimmer Natural Nail System, Antegrade Femoral Interlock Module, standard, nonsterile... | Zimmer GmbH | HSB | ||
| Z-0167-2010 | Koodinat M/MP Patient Table used with Multistar Model 6239003. The device is used as... | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0166-2010 | Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as... | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-2313-2009 | Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc... | Penumbra Inc. | DQY | ||
| Z-1998-2009 | Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550... | Lumitex Medical Devices, Inc. | FDG |
