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-0217-2008 | Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown... | Skf USA Inc | |||
| Z-0216-2008 | Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown... | Skf USA Inc | |||
| Z-0215-2008 | Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000, SKF USA, Inc. Norristown... | Skf USA Inc | |||
| Z-0077-2008 | Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO... | Zimmer GmbH | JWH | ||
| Z-0076-2008 | Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok... | Zimmer GmbH | JWH | ||
| Z-1265-2007 | Spectrum Designs Medical Anatomical Chin Implant; Catalog Number 250-134S; Lot # 31140... | Spectrum Designs, Inc. | LZK | ||
| Z-1264-2007 | Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and... | Spectrum Designs, Inc. | LZK | ||
| Z-0015-2008 | Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro... | Thermo Fisher Scientific Oy | JIF | ||
| Z-0006-2008 | GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance... | GE Healthcare | BSF | ||
| Z-0273-2008 | Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Manufactured by Siemens... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0272-2008 | Siemens ECAT EXACT HR 47, Catalog No. 2956261, PET/CT Scanner, Manufactured by Siemens... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0271-2008 | Siemens ECAT EXACT 47, Catalog No. 1788772, PET/CT Scanner, Manufactured by Siemens... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0270-2008 | Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Manufactured by Siemens Medical... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0269-2008 | Siemens ECAT ACCEL, Catalog No. 3554479, PET/CT Scanner, Manufactured by Siemens Medical... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0252-2008 | Biograph DUO LSO, Biograph PET/CT Scanner, Catalog No. 8728813, Manufactured by Siemens... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0251-2008 | Biograph 64-3 Ring, Biograph PET/CT Scanner, Catalog No. 8727450, Manufactured by Siemens... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0250-2008 | Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728573, Manufactured by Siemens... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0249-2008 | Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728854, Manufactured by Siemens... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0248-2008 | Biograph 40 TruePoint, Biograph PET/CT Scanner, Catalog No. 10097303, Manufactured by... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0247-2008 | Biograph 40 - 3 Ring, Biograph PET/CT Scanner, Catalog No. 10097233, Manufactured by... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0246-2008 | Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Manufactured by Siemens Medical... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0058-2008 | Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag... | Remington Medical | EXF | ||
| Z-0912-2007 | Philips Multi Diagnost Eleva | Philips North America LLC | IZI | ||
| Z-0911-2007 | Philips Omni Diagnost Eleva | Philips North America LLC | IZI | ||
| Z-0910-2007 | Philips Easy Diagnost Eleva | Philips North America LLC | KPR | ||
| Z-0909-2007 | Philips Easy Diagnost X-Ray System | Philips North America LLC | IXR | ||
| Z-0908-2007 | Philips Digital Diagnost X-Ray system | Philips North America LLC | MQB | ||
| Z-0907-2007 | Philips Bucky DIagnost X-Ray System | Philips North America LLC | KPR | ||
| Z-0064-2008 | Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20)... | Abbott Diagnostic International, Ltd. | KXT | ||
| Z-1219-2007 | Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in... | Molnlycke Health Care | |||
| Z-1108-2008 | UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access... | Siemens Healthcare Diagnostics Inc. | MMI | ||
| Z-0328-2008 | Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and... | Boston Scientific Corporation | DYB | ||
| Z-1242-2007 | HealthPax Cranial Electrotherapy Stimulator | Health Directions, Inc | JXK | ||
| Z-0516-2008 | PremierEdge MICROSURGICAL KNIFE, 3.0mm Thin Slit Knife, Item Code/REF: PE4830-TL; OASIS... | Oasis Medical, Inc. | HNN | ||
| Z-0515-2008 | PremierEdge MICROSURGICAL KNIFE , 2.85mm Thin Slit Knife, Item Code/REF: PE4828-TL; OASIS... | Oasis Medical, Inc. | HNN | ||
| Z-0514-2008 | PremierEdge MICROSURGICAL KNIFE, 2.75mm Thin Slit Knife, Item Code/REF: PE4827-TL; OASIS... | Oasis Medical, Inc. | HNN | ||
| Z-0513-2008 | PremierEdge MICROSURGICAL KNIFE, 2.4mm Thin Slit Knife, Item Code/REF: PE 4824-TL... | Oasis Medical, Inc. | HNN | ||
| Z-0512-2008 | PremierEdge MICROSURGICAL KNIFE, 3.2mm Slit Knife; Item Code/REF: PE 3832; OASIS... | Oasis Medical, Inc. | HNN | ||
| Z-0511-2008 | PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife - Straight Item Code/REF: PE 3830S... | Oasis Medical, Inc. | HNN | ||
| Z-0510-2008 | PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife, Item Code/REF: PE 3830; OASIS... | Oasis Medical, Inc. | HNN | ||
| Z-0509-2008 | PremierEdge MICROSURGICAL KNIFE, 2.85mm Slit Knife, Item Code/REF: PE 3828; OASIS... | Oasis Medical, Inc. | HNN | ||
| Z-0508-2008 | PremierEdge MICROSURGICAL KNIFE, 2.75mm Slit Knife, Item Code/REF: PE 3827; OASIS... | Oasis Medical, Inc. | HNN | ||
| Z-0507-2008 | PremierEdge MICROSURGICAL KNIFE, 2.65mm Slit Knife, Item Code/REF: PE 3826; OASIS... | Oasis Medical, Inc. | HNN | ||
| Z-0506-2008 | PremierEdge MICROSURGICAL KNIFE,2.0mm Angled Crescent Tunnel Knife, Angled, Item... | Oasis Medical, Inc. | HNN | ||
| Z-0505-2008 | PremierEdge MICROSURGICAL KNIFE, 3.0mm Round, Tunnel Knife, Item Code/REF: PE 3630, OASIS... | Oasis Medical, Inc. | HNN | ||
| Z-0504-2008 | PremierEdge MICROSURGICAL KNIFE, 23g MVR Knife, Item Code/REF: PE3523, OASIS Glendora... | Oasis Medical, Inc. | HNN | ||
| Z-0503-2008 | PremierEdge MICROSURGICAL KNIFE ,4.0mm Implant Knife, Item Code/REF: PE 3440; OASIS... | Oasis Medical, Inc. | HNN | ||
| Z-0502-2008 | PremierEdge MICROSURGICAL KNIFE, 3.5mm Implant Knife, Item Code/REF: PE 3435, OASIS... | Oasis Medical, Inc. | HNN | ||
| Z-0501-2008 | PremierEdge MICROSURGICAL KNIFE, 3.2mm Implant Knife, Item Code/REF: PE 3432, OASIS... | Oasis Medical, Inc. | HNN | ||
| Z-0500-2008 | PremierEdge MICROSURGICAL KNIFE , 2.5-3.0mm Clear Cornea Knife - Trapezoid, Item... | Oasis Medical, Inc. | HNN |
