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-0715-04 | Apex Pilot Shaft 13mm | VQ Orthocare | HTO | ||
| Z-0714-04 | Apex Pilot Shaft, 11.5mm | VQ Orthocare | HTO | ||
| Z-0713-04 | Apex Pilot Shaft, 10mm | VQ Orthocare | HTO | ||
| Z-0787-03 | FreshLook Colors (phemfilcon A), 7-day Extended wear soft (hydrophilic) contact lens... | Alcon Laboratories | LPM | ||
| Z-0678-03 | Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR... | CliniSys, Inc | JQP | ||
| Z-0546-03 | Palacos R radiopaque bone cement, 40 gram. Product number 424800. | Zimmer GmbH | LOD | ||
| Z-0559-03 | Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in... | Zimmer Spine, Inc. | LXH | ||
| Z-0470-03 | AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B | Encision, Inc. | GEI | ||
| Z-0668-03 | X-ray, Computed Tomography, Model TSX101A | Canon Medical Systems USA, Inc. | JAK | ||
| Z-0630-03 | OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test... | Lifescan, Inc. | CGA | ||
| Z-0565-06 | AUDICOR 200 D Inovise Part Number 30047 (console part number 20158). | Inovise Medical, Inc. | DPS | ||
| Z-0632-03 | Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT PART A Model/List... | Abbott Medical | JPK | ||
| Z-0541-03 | Coulter LH 700 Series Hematology Analyzers | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0586-03 | MultiDiagnost 4 - x-ray system, multi functional/universal system for general use. | Philips North America LLC | JAA | ||
| Z-0558-03 | Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic... | Ortho-Clinical Diagnostics, Inc. | |||
| Z-0578-03 | Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label... | ZOLL Manufacturing Corporation | |||
| Z-0355-06 | Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0898-03 | Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences... | Revvity Health Sciences, Inc. | JJT | ||
| Z-0603-03 | Bard Orbiter PV Steerable Catheter Item #: 320100 (Marketed in Europe Only) | Boston Scientific Corporation | |||
| Z-0602-03 | Bard Orbiter ST Artrial Mapping Steerable Catheter Item... | Boston Scientific Corporation | |||
| Z-0601-03 | Bard Stinger SM Ablation Catheter Item Numbers 210001SM 218501SM 210002SM 218502SM 21000... | Boston Scientific Corporation | |||
| Z-0600-03 | Bard Stinger S Ablation Catheter: Item Numbers 210001S 218501S 6210015S 210002S 218502S... | Boston Scientific Corporation | |||
| Z-0599-03 | Bard Stinger M Ablation Catheters: Item Numbers 210001M 218501M 210002M 218502M 210003M... | Boston Scientific Corporation | |||
| Z-0598-03 | Bard Stinger Ablation Catheter: Item Numbers 210001 218501 L210001 210002 218502 L210002 2... | Boston Scientific Corporation | |||
| Z-0489-03 | Lasik Spears Blunt (5) Catalog #: U/S32-100 | Ultracell Medical Technologies, Inc. | HOZ | ||
| Z-0488-03 | PVA Foam Surgical Spears Catalog #: OASIS0525 | Ultracell Medical Technologies, Inc. | HOZ | ||
| Z-0487-03 | Ultrakleen KSponge II Spears Catalog #: K20-5012 | Ultracell Medical Technologies, Inc. | HOZ | ||
| Z-0486-03 | Rhinocell Nasal 6.0 x 1.5 x 2.0 w/Airway Catalog #: BMPNP601520A | Ultracell Medical Technologies, Inc. | EMX | ||
| Z-0485-03 | Otocell Ear Wick 15mm Catalog #: BMPEW0915 | Ultracell Medical Technologies, Inc. | KCN | ||
| Z-0484-03 | Ultacell Diamond Knife Cleaning Block 15mm Catalog #: 40462 | Ultracell Medical Technologies, Inc. | MDZ | ||
| Z-0483-03 | Ultracell Ear Wick 9mm DIA x 24 mm Catalog #: 30310-C | Ultracell Medical Technologies, Inc. | KCN | ||
| Z-0482-03 | Ultracell Ear Wick Fenestrated 9mm DIA x 15mm Catalog #: 30305-C | Ultracell Medical Technologies, Inc. | KCN | ||
| Z-0481-03 | Ultracell Ear Wick 7mm DIA x 12 mm ( Pediatric) Catalog #: 30301-C | Ultracell Medical Technologies, Inc. | KCN | ||
| Z-0480-03 | Ultracell Ear Wick 9mm DIA x 15 mm Catalog #: 30300-C | Ultracell Medical Technologies, Inc. | KCN | ||
| Z-0479-03 | Ultracell Classic Anatomical Nasal Packing w/Tube (pediatric) Catalog # 10126-CT | Ultracell Medical Technologies, Inc. | EMX | ||
| Z-0466-03 | ''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged... | Diversatek Healthcare Inc | FFT | ||
| Z-0490-03 | 8.0 cm Nasal Classic Anatomical Nasal w/tube Catalog #:10120-CT | Ultracell Medical Technologies, Inc. | EMX | ||
| Z-0478-03 | Ultracell 8.0 cm Nasal Packing w/tube Catalog #:10110-CT | Ultracell Medical Technologies, Inc. | EMX | ||
| Z-0705-03 | Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5... | Surgical Specialties Corp | HNN | ||
| Z-0588-03 | Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and... | Howmedica Osteonics Corp | JDI | ||
| Z-0587-03 | Modular femoral and proximal tibial replacement system consisting of femoral head/neck... | Howmedica Osteonics Corp | JDI | ||
| Z-0477-03 | Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head... | Zimmer GmbH | LPH | ||
| Z-0476-03 | Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head... | Zimmer GmbH | LPH | ||
| Z-0475-03 | Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head... | Zimmer GmbH | LPH | ||
| Z-0474-03 | Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head... | Zimmer GmbH | LPH | ||
| Z-0473-03 | Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head... | Zimmer GmbH | LPH | ||
| Z-0472-03 | Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head... | Zimmer GmbH | LPH | ||
| Z-0461-03 | Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.5 neck length... | Zimmer GmbH | LZO | ||
| Z-0460-03 | Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.0 neck length... | Zimmer GmbH | LZO | ||
| Z-0459-03 | Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a 0 neck length on... | Zimmer GmbH | LZO |