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-1223-2009 | MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infared laser... | Flir Systems | REQ | ||
| Z-1174-2009 | Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do... | Integra LifeSciences Corporation | FRO | ||
| Z-1317-2009 | Hill-Rom TotalCare Bed, Model P1900. The TotalCare (R) Bed System is intended to... | Hill-Rom Inc. | FNL | ||
| Z-1420-2009 | STERRAD NX Sterilization System Product Code 10033 The STERRAD Sterilization System is... | Advanced Sterilization Products | MLR | ||
| Z-1419-2009 | STERRAD 50 Sterilization System Product Code 10050 The STERRAD Sterilization System is... | Advanced Sterilization Products | FLF | ||
| Z-0918-2011 | Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips... | Philips North America LLC | IZI | ||
| Z-0917-2011 | Philips MultiDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips... | Philips North America LLC | IZI | ||
| Z-0916-2011 | Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips... | Philips North America LLC | IZI | ||
| Z-2000-2011 | Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1548-2009 | Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental... | Gendex Corp. | MUH | ||
| Z-1721-2009 | Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion. | Medtec LLC | IXQ | ||
| Z-2059-2015 | Class II | Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number... | Exactech, Inc. | MNH | |
| Z-0267-2010 | Nasal Mucosal Atomizer Device without syringe, LATEX FREE For Single Patient Use Only... | Sharn, Inc. | CCT | ||
| Z-0266-2010 | Nasal Mucosal Atomizer Device with syringe, LATEX FREE For Single Patient Use Only... | Sharn, Inc. | CCT | ||
| Z-0265-2010 | Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single... | Sharn, Inc. | CCT | ||
| Z-0050-2012 | Access Immunoassay Systems Total hCG. The Access Total hCG assay is a paramagnetic... | Siemens Healthcare Diagnostics Inc. | JHI | ||
| Z-1207-2009 | Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle... | Zimmer GmbH | JQC | ||
| Z-1927-2009 | Malibu Polyaxial Reduction Screw, 6.5 x 50mm Part Number 13-6550 Malibu Spinal System... | Seaspine, Inc. | KWP | ||
| Z-1926-2009 | Malibu Polyaxial Reduction Screw, 6.5 x 45mm Part Number 13-6545 Malibu Spinal System... | Seaspine, Inc. | KWP | ||
| Z-1925-2009 | Malibu Polyaxial Reduction Screw, 6.5 x 40mm Part Number 13-6540 Malibu Spinal System... | Seaspine, Inc. | KWP | ||
| Z-1924-2009 | Malibu Polyaxial Screw, 7.5 x 70mm Part Number 12-7570 Malibu Spinal System when used... | Seaspine, Inc. | KWP | ||
| Z-1923-2009 | Malibu Polyaxial Screw, 7.5 x 35mm Part Number 12-7535 Malibu Spinal System when used... | Seaspine, Inc. | KWP | ||
| Z-1922-2009 | Malibu Polyaxial Screw, 6.5 x 50mm Part Number 12-6550 Malibu Spinal System when used... | Seaspine, Inc. | KWP | ||
| Z-1921-2009 | Malibu Polyaxial Screw, 6.5 x 45mm Part Number 12-6545 Malibu Spinal System when used... | Seaspine, Inc. | KWP | ||
| Z-1920-2009 | Malibu Polyaxial Screw, 6.5 x 40mm Part Number 12-6540 Malibu Spinal System when used... | Seaspine, Inc. | KWP | ||
| Z-1919-2009 | Malibu Polyaxial Screw, 6.5 x 35mm Part Number 12-6535 Malibu Spinal System when used... | Seaspine, Inc. | KWP | ||
| Z-1918-2009 | Malibu Polyaxial Screw, 4.5 x 30mm Part Number 12-4530 Malibu Spinal System when used... | Seaspine, Inc. | KWP | ||
| Z-1237-2009 | Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120... | CareFusion 303, Inc | FRN | ||
| Z-1621-2009 | GUIDANT VITALITY DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model... | Boston Scientific Corporation | LWP | ||
| Z-1620-2009 | Guidant Contak Renewal 3 CRT-D Model H170; 3CRT-D, Model H175; 3HE CRT-D, Model H177; 3HE... | Boston Scientific Corporation | LWP | ||
| Z-1517-2013 | Class II | lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145... | Invatec S.p.A. | DXE | |
| Z-1181-2009 | Pilling(R) Coronary Scissors, 120Deg w/bar, Catalog numbers: and 352178, Teleflex... | Teleflex Medical | LRW | ||
| Z-1180-2009 | Beall(R) Circumflex Artery Scissors, Catalog numbers: 352169, Teleflex Medical, Research... | Teleflex Medical | LRW | ||
| Z-1179-2009 | Pilling(R) Coronary Scissors, 120Deg 7", Catalog numbers: 352168, Teleflex Medical... | Teleflex Medical | LRW | ||
| Z-1178-2009 | Pilling(R) Coronary Scissors, 90Deg 7", Catalog numbers: 352167, Teleflex Medical... | Teleflex Medical | LRW | ||
| Z-1177-2009 | Pilling(R) Coronary Scissors, 60Deg 7", Catalog numbers: 352166, Teleflex Medical... | Teleflex Medical | LRW | ||
| Z-1176-2009 | Pilling(R) Coronary Scissors, 45Deg 7", Catalog numbers: 352165, Teleflex Medical... | Teleflex Medical | LRW | ||
| Z-1175-2009 | Pilling(R) Coronary Scissors, 25Deg 7", Catalog numbers: 352164, Teleflex Medical... | Teleflex Medical | LRW | ||
| Z-1351-2009 | Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for... | Howmedica Osteonics Corp | JDS | ||
| Z-1350-2009 | Stryker, Gamma3S Trochanteric Nail 170, Operative Technique for Hip Fracture System. | Howmedica Osteonics Corp | JDS | ||
| Z-1349-2009 | Stryker, Gamma3 Plus Obese Targeting System, Operative Technique for Hip Fracture System... | Howmedica Osteonics Corp | JDS | ||
| Z-2173-2010 | Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number... | Sgarlato Med, LLC | KWH | ||
| Z-1539-2012 | Mitaka Point Setter, holding system for surgical instruments. Holding surgical... | Mitaka USA, Inc. | GWG | ||
| Z-0899-2011 | Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF... | Concentric Medical, Inc. | GBS | ||
| Z-1232-2009 | GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6 ,5.0.7, 5.0.8 and 4.1. The CIC... | GE Healthcare | DSI | ||
| Z-1122-2009 | ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K | Hill-Rom Inc. | FSY | ||
| Z-1231-2009 | Stryker Electric Stretcher with the Quick Drop CPR option, Model 1550. | Stryker Medical | FPO | ||
| Z-1230-2009 | Stryker Electric Stretcher with the Quick Drop CPR option, Model 1050. | Stryker Medical | FPO | ||
| Z-1307-2009 | Hydrophilic Guidewire, Catalog Number: VM18352, .035/150 cm, regular/angled/standard... | Argon Medical Devices, Inc | DQX | ||
| Z-1306-2009 | Hydrophilic Guidewire, Catalog Number: TVS3010, .035/150 cm, regular/angled/standard... | Argon Medical Devices, Inc | DQX |