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-1261-06 | Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7... | Radiometer America, Inc | CHL | ||
| Z-1268-06 | GammaWin software, part number GM11019110, versions up to and including 1.62, for the... | Varian Medical Systems, Inc. | JAQ | ||
| Z-0913-06 | Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet... | Bard Peripheral Vascular Inc | FCG | ||
| Z-0816-2007 | Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging... | Palodex Group Oy | EDH | ||
| Z-1224-06 | Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000... | Medisurg Research & Management Corp | NCR | ||
| Z-1237-06 | GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment... | W. L. Gore & Associates, Inc. | MIH | ||
| Z-1236-06 | GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment... | W. L. Gore & Associates, Inc. | MIH | ||
| Z-1254-06 | VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only... | Medtronic, Inc. | GXZ | ||
| Z-1205-06 | 3D-I/III Ceiling Stand. Diagnostic x-ray tube mount | Siemens Medical Solutions USA, Inc. | IYB | ||
| Z-1104-06 | AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-1817-2009 | Lateral Decubitus Alignment Guide, Non Sterile; manual surgical instrument. The MIS Hip... | Howmedica Osteonics Corp | HWA | ||
| Z-2444-2008 | Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by... | Zimmer GmbH | HAW | ||
| Z-1101-06 | Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold... | Ethicon, Inc | DWF | ||
| Z-0895-06 | Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F, Catalog #: 1721... | Boston Scientific Corporation | KRA | ||
| Z-0949-2008 | Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number... | Medtronic, Inc. | BSP | ||
| Z-0948-2008 | Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon... | Medtronic, Inc. | BSP | ||
| Z-1115-06 | Hitachi AIRIS II MRI System | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-0400-2016 | Class II | Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number... | Philips North America LLC | JAK | |
| Z-1506-06 | Ruggles Leyla Ball Joint Clamp, MODEL/CATALOG #: R2383 . The Leyla Ball Joint Clamp is... | J. Jamner Surgical Instruments, Inc. | FWZ | ||
| Z-0044-2007 | 0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by... | Excelsior Medical LLC | NGT | ||
| Z-1077-06 | Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For... | Biomerics | LKF | ||
| Z-1190-06 | Vapofils with Stainless Steel Block Ends, Item Number V0507S (Sevofluane). The vapofil... | Southmedic Inc. | CAD | ||
| Z-1189-06 | Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil... | Southmedic Inc. | CAD | ||
| Z-0859-06 | Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation... | Medtronic, Inc. | GEI | ||
| Z-0926-06 | Endopath Probe Plus II, Flexible Fiber Canula, 5mm shaft, 29cm length, Code EPS13. | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0925-06 | Endopath Probe Plus II, Open End Suction/Irrigation Canula, 10mm shaft, 34 cm length... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0924-06 | Endopath Probe Plus II, Needle Electrode, 5mm shaft, 29cm length, hollow tip electrode... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0923-06 | Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 29cm length, hollow tip... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0922-06 | Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 29cm length, hollow tip electrode... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0921-06 | Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 34 cm length, hollow tip... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0848-06 | Cook Esophageal Dilator Set --------------------------------------Small label applied by... | Wilson-Cook Medical Inc. | KOG | ||
| Z-0920-06 | Endopath Probe Plus II, Right Ange Electrode, 5 mm shaft, 34 cm length, hollow tip... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0919-06 | Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 34 cm length, hollow tip electrode... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0918-06 | Endopath Probe Plus II, Hand Controlled PencilGrip Handle, Product Code EPH04. | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0917-06 | Endopath Probe Plus II, Hand-Controlled PistolGrip Handle, Product Code EPH02. | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0916-06 | Endopath Probe Plus II, Foot-Controlled PistolGrip Handle, Product Code EPH01. | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0915-06 | Endopath Probe Plus II, Hook Electrode, 5 mm Shaft, 34 cm length, hollow tip electrdode... | Ethicon Endo-Surgery Inc | GCJ | ||
| Z-0871-06 | Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY... | Jubilant Hollisterstier LLC | LDH | ||
| Z-1095-06 | Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm., Edwards Lifesciences | Edwards Lifesciences LLC | DWF | ||
| Z-1094-06 | Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm. , Edwards Lifesciences | Edwards Lifesciences LLC | DWF | ||
| Z-1093-06 | Aortic Perfusion Cannula with plastic tip, 22 Fr. x 23 cm, Edwards Lifesciences | Edwards Lifesciences LLC | DWF | ||
| Z-1092-06 | Duraflo Treated Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm, Edwards... | Edwards Lifesciences LLC | DWF | ||
| Z-1091-06 | Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm Edwards Lifesciences | Edwards Lifesciences LLC | DWF | ||
| Z-1090-06 | Duraflo Treated Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm., Edwards... | Edwards Lifesciences LLC | DWF | ||
| Z-1089-06 | Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm Edwards Lifesciences | Edwards Lifesciences LLC | DWF | ||
| Z-0708-2007 | CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01... | Abbott Medical | GIF | ||
| Z-1245-06 | Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834 | Siemens Healthcare Diagnostics Inc. | LOQ | ||
| Z-0903-06 | Rascal 600F and 600T scooters, unspecified power wheelchair. | Electric Mobility | ITI | ||
| Z-1086-06 | St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia)... | Abbott Medical | DYB | ||
| Z-1201-06 | Bausch & Lomb * ReNu with MoistureLoc, Multi-purpose soft contact lens solution *... | Bausch & Lomb Incorporated | LPN |