Medical Device
Manufacturing
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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

59,476 records, page 948 of 1190
FDA device recalls, page 948 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1904-2009ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN...Memphis Fertility Laboratory IncNUC
Z-1966-2009Apex Hip System Bipolar Head, 22.225mm ID, 38 mm OD Product Code: H3-82238. Intended...Omni Life Science, Inc.KWY
Z-0465-2010Shower Seat, Rotating, Catalog number 727152100Nutech Manufacturing CorpIKX
Z-0464-2010Shower Seat, Non-rotating, Catalog number 727152000Nutech Manufacturing CorpIKX
Z-0463-2010Bath Safe Adjustable Transfer Bench, Catalog numbers 727142500, 727142501, and MDS86960RNutech Manufacturing CorpIKX
Z-0462-2010Bath Safe Adjustable Shower Seat, With Arms and Back, Catalog numbers 727142120...Nutech Manufacturing CorpIKX
Z-0461-2010Bath Safe Adjustable Shower Seat, With Back, Catalog number 727142101Nutech Manufacturing CorpIKX
Z-0460-2010Bath Safe Adjustable Shower Seat, With Arms, Model numbers 727142020, 727142021, and...Nutech Manufacturing CorpIKX
Z-0459-2010Bath Safe Adjustable Shower Seat, Without Back and Arms, Catalog number 727142001Nutech Manufacturing CorpIKX
Z-2010-2009Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The...Instrumentation Industries, IncorporatedBTO
Z-1425-2012Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative...Abbott MedicalCIG
Z-1997-2009MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous...3M ImtecKKO
Z-1811-2009BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA.Becton Dickinson & CoFMF
Z-1795-2009HeartStart MRx/MRxE Defibrillator/Monitor Models: M3536A (HeartStart MRx) and M3536J...Philips North America LLCmkj
Z-0599-2010Stryker MIS Bur, 3.0mm Neuro Diamond Course, sterile, Stryker Instruments, Kalamazoo, MI...Stryker Corp.HBE
Z-0598-2010Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF...Stryker Corp.HBE
Z-0597-2010Stryker MIS Bur, 3.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF...Stryker Corp.HBE
Z-0596-2010Stryker MIS Bur, 2.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF...Stryker Corp.HBE
Z-0595-2010Stryker MIS Bur, 2.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF...Stryker Corp.HBE
Z-0545-2010Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged in 8 piece shelf...Terumo Cardiovascular Systems CorporationKFM
Z-0544-2010Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf...Terumo Cardiovascular Systems CorporationKFM
Z-1667-2009Diagnost 76Philips North America LLCJAA
Z-1666-2009Diagnost 96/97 DSIPhilips North America LLCJAA
Z-1665-2009OmniDiagnostPhilips North America LLCJAA
Z-1664-2009MultiDiagnost MD4Philips North America LLCJAA
Z-1663-2009MultiDiagnost MD3Philips North America LLCJAA
Z-1662-2009UroDiagnostPhilips North America LLCJAA
Z-1661-2009LithoDiagnostPhilips North America LLCJAA
Z-1660-2009Easy Diagnost DigitalPhilips North America LLCJAA
Z-1659-2009EasyDiagnostPhilips North America LLCJAA
Z-1891-2009Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex...Teleflex MedicalBTR
Z-1890-2009Sheridan Preformed Cuffed Tracheal Tube, Nasal 6.5, Catalog Number: 5-22313, Teleflex...Teleflex MedicalBTR
Z-1877-2009Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For...Boston Scientific CorporationGEI
Z-1876-2009Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For...Boston Scientific CorporationGEI
Z-2049-2009Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter...Penumbra Inc.DQY
Z-1894-2009Baxter Minicap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp; six sets...Baxter Healthcare CorporationKDJ
Z-1892-2009BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems...Philips North America LLCKPS
Z-1712-2009Twin-Pass Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only...Vascular Solutions LLCDQY
Z-1893-2009Baxter Minicap Extended Life PD Transfer Set (6") with Twist Clamp; six sets per carton...Baxter Healthcare CorporationKDJ
Z-0388-2010Zimmer Natural Nail System, Connecting Knob, nonsterile, Zimmer, Warsaw, IN; REF...Zimmer GmbHHSB
Z-0387-2010Zimmer Natural Nail System, Tibial Module, nonsterile, Zimmer, Warsaw, IN; REF...Zimmer GmbHHSB
Z-0386-2010Zimmer Natural Nail System, Antegrade Femoral Recon Module, small, nonsterile, Zimmer...Zimmer GmbHHSB
Z-0385-2010Zimmer Natural Nail System, Antegrade Femoral Interlock Module, small, nonsterile...Zimmer GmbHHSB
Z-0384-2010Zimmer Natural Nail System, Antegrade Femoral interlock Module, tall, nonsterile, Zimmer...Zimmer GmbHHSB
Z-0383-2010Zimmer Natural Nail System, Antegrade Femoral Recon Module, standard, nonsterile, Zimmer...Zimmer GmbHHSB
Z-0382-2010Zimmer Natural Nail System, Antegrade Femoral Interlock Module, standard, nonsterile...Zimmer GmbHHSB
Z-0167-2010Koodinat M/MP Patient Table used with Multistar Model 6239003. The device is used as...Siemens Medical Solutions USA, Inc.IZI
Z-0166-2010Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as...Siemens Medical Solutions USA, Inc.IZI
Z-2313-2009Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc...Penumbra Inc.DQY
Z-1998-2009Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550...Lumitex Medical Devices, Inc.FDG