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-1041-2008 | Anspach Xmax Pneumatic Motor System; ENT Surgical Drill, including handpiece and... | The Anspach Effort, Inc. | ERL | ||
| Z-1040-2008 | Anspach MicroMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and... | The Anspach Effort, Inc. | ERL | ||
| Z-0709-2007 | Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version... | Abbott Medical | NBW | ||
| Z-1039-2008 | Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and... | The Anspach Effort, Inc. | ERL | ||
| Z-0411-2007 | Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material... | Medtronic Sofamor Danek Instrument Manufacturing | MNI | ||
| Z-0365-2007 | Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain... | Terang Nusa (Malaysia) Sdn. Bhd. | KGO | ||
| Z-0362-2007 | Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with... | Hologic, Inc. | KNW | ||
| Z-0378-2007 | Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm... | Abbott Medical | KAC | ||
| Z-0356-2007 | Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in... | Roche Diagnostics GmbH | CFN | ||
| Z-0431-2007 | AcrySof Intraocular Lens | Alcon Laboratories | MFK | ||
| Z-0430-2007 | AcrySof ReSTOR Intraocular Lens | Alcon Laboratories | MFK | ||
| Z-0371-2007 | FD 20/10 X-Ray System, Angiograph, biplane, digital Allura FD, 10' and 20' detectors | Philips North America LLC | IZI | ||
| Z-0370-2007 | FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10' detector | Philips North America LLC | IZI | ||
| Z-0369-2007 | Allura FD20 x-ray system, angiograph, monoplane, digital Allura FD with a 20' detector FD | Philips North America LLC | IZI | ||
| Z-0368-2007 | Allura FD 10 FC, X-Ray System, angiographic - a monoplane, digital Allura FD (flat... | Philips North America LLC | IZI | ||
| Z-0367-2007 | Allura Mono X-Ray System, angiographic - monoplane, analog Allura with a 12' and 15'... | Philips North America LLC | IZI | ||
| Z-0366-2007 | Philips Integris Allura x-ray systems angiographic - Allura 9 F/C (floor and ceiling... | Philips North America LLC | IZI | ||
| Z-0429-2007 | AcrySof ReSTOR Intraocular Lens | Alcon Laboratories | MFK | ||
| Z-0496-2007 | Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920... | Bausch & Lomb Incorporated | HQE | ||
| Z-0495-2007 | Bausch & Lomb Lightning High Speed Vitrectomy Cutter, Catalog #CX4804, 1/20-gauge high... | Bausch & Lomb Incorporated | HQE | ||
| Z-0388-2007 | Boston Scientific Mach 1 Peripheral Guide Catheter, 6F, 55cm, LIMA Tip Shape, UPN #... | Boston Scientific Corporation | DQY | ||
| Z-0387-2007 | Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Voda Left Curve... | Boston Scientific Corporation | DQY | ||
| Z-0386-2007 | Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091'', Amplatz Left... | Boston Scientific Corporation | DQY | ||
| Z-0385-2007 | Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091'', Amplatz Right... | Boston Scientific Corporation | DQY | ||
| Z-0384-2007 | Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Multipurpose... | Boston Scientific Corporation | DQY | ||
| Z-0383-2007 | Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Voda Left Curve... | Boston Scientific Corporation | DQY | ||
| Z-0382-2007 | Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary... | Boston Scientific Corporation | DQY | ||
| Z-0416-2007 | ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01... | Abbott Medical | JJE | ||
| Z-0415-2007 | ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01... | Abbott Medical | JJE | ||
| Z-0364-2007 | i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Ref 04J50-01... | Abbott Medical | GJS | ||
| Z-0642-2007 | Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic... | Boston Scientific Corporation | DQX | ||
| Z-0617-2007 | Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268. | Terumo Cardiovascular Systems Corporation | KFM | ||
| Z-2227-2009 | 3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT... | ZimVie US Corp LLC | NDA | ||
| Z-0507-2007 | The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography... | GE Healthcare | JAK | ||
| Z-0506-2007 | The LightSpeed RT16 CT Scanner System is indicated for head and whole body X-ray Computed... | GE Healthcare | JAK | ||
| Z-0544-2007 | Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4''... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0543-2007 | Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4''... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0522-2007 | Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS... | Exactech, Inc. | JWH | ||
| Z-0389-2007 | ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120. | Medtronic, Inc. | FGE | ||
| Z-0470-2007 | International Technidyne Corporation (ITC) ProTime Microcoagulation System... | Accriva Diagnostics, Inc. | GJS | ||
| Z-0484-2007 | Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FRN | ||
| Z-0483-2007 | Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FRN | ||
| Z-0392-2007 | ACS Rotating Hemostatic Valve, .115 inch, for use with a dilatation catheter - Reference... | Abbott Vascular | DTL | ||
| Z-0391-2007 | ACS DUOSTAT Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter... | Abbott Vascular | DTL | ||
| Z-0390-2007 | ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference... | Abbott Vascular | DTL | ||
| Z-0361-2007 | Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892 | Sekisui Diagnostics P.E.I. Inc. | DKJ | ||
| Z-0489-2007 | LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius... | Synthes GmbH | HRS | ||
| Z-0400-2007 | Triathlon X3 CR Tibial Bearing Insert Size #7 - 11MM Ref # 5530-G-711 2011-09 Howmedica... | Howmedica Osteonics Corp | JWH | ||
| Z-0399-2007 | Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref #... | Howmedica Osteonics Corp | JWH | ||
| Z-0612-2007 | Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100 | Maquet Cardiovascular LLC | MWS |