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-0577-03 | Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10. | Cook Biotech, Inc. | DXY | ||
| Z-0721-03 | AEROSET System Software version 1.00ER005 Catalog Number 2-89996-01 and 1.00ER005.2... | Abbott Medical | JJE | ||
| Z-0653-03 | Fetal Cell Stain Kit No. S0412-00, contents include 3 x 120ml Fetal Cell Fixing Solution... | Simmler Inc | |||
| Z-0458-03 | 100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL... | Baxter Healthcare Corporation | FOZ | ||
| Z-0457-03 | 10 U/mL Heparin Lock Flush Solution USP, 5mL in 12 mL Syringe, code 2K6030; Baxter... | Baxter Healthcare Corporation | FOZ | ||
| Z-0456-03 | 0.9% Sodium Chloride Flush Syringe; Baxter Healthcare Corporation, Deerfield, IL 60015... | Baxter Healthcare Corporation | FOZ | ||
| Z-0943-03 | Fixion PF (''Proximal Femur'') Hip Peg. Fixion PF Hip Pegs are manufactured in the... | Disc Orthopaedic Technologies Inc | NDH | ||
| Z-0352-03 | Surgical Mesh | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | 79F | ||
| Z-0691-03 | TDx/TDxFLx TDx/TDxFLX Tricyclic Antidepressant Reagent Distributed under the... | Abbott Diagnostic International, Ltd. | 91 | ||
| Z-0690-03 | ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx... | Abbott Diagnostic International, Ltd. | 91 | ||
| Z-0689-03 | AxSYM Tricyclic Antidpressants Reagent. Distributied under the following... | Abbott Diagnostic International, Ltd. | 91 | ||
| Z-0571-03 | Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential... | Siemens Healthcare Diagnostics Inc. | |||
| Z-0556-03 | ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only | Solta Medical, Inc. | GEI | ||
| Z-0494-03 | Access Progesterone Assay, Part number 33550. | Siemens Healthcare Diagnostics Inc. | JLS | ||
| Z-0497-03 | Reference Library Interface Version 5.3 | CliniSys, Inc | JQP | ||
| Z-0613-03 | REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a... | Remel Inc | JTN | ||
| Z-1080-04 | FDP Plasma kit provides reagents for the detection and semi-quantitation of... | Diagnostica Stago, Inc. | DAP | ||
| Z-0524-03 | Stryker brand Neptune waste management system; model 711-27-1. | Stryker Corp. | FYD | ||
| Z-0467-03 | Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog... | Howmedica Osteonics Corp | MEH | ||
| Z-0539-03 | Conformer - Large with holes (Sterile) | Gulden Ophthalmics | HQX | ||
| Z-0538-03 | Conformer - Medium with holes (Sterile) | Gulden Ophthalmics | HQX | ||
| Z-0537-03 | Conformer - Small with holes (Sterile) | Gulden Ophthalmics | HQX | ||
| Z-0536-03 | Conformer - Large (Sterile) | Gulden Ophthalmics | HQX | ||
| Z-0535-03 | Conformer - Medium (Sterile) | Gulden Ophthalmics | HQX | ||
| Z-0534-03 | Conformer - Small (Sterile) | Gulden Ophthalmics | HQX | ||
| Z-0533-03 | Venus Eye Sphere 22 mm (Sterile) | Gulden Ophthalmics | HQX | ||
| Z-0532-03 | Venus Eye Sphere 20 mm (Sterile) | Gulden Ophthalmics | HQX | ||
| Z-0531-03 | Venus Eye Sphere 18 mm (Sterile) | Gulden Ophthalmics | HQX | ||
| Z-0530-03 | Venus Eye Sphere 16 mm (Sterile) | Gulden Ophthalmics | HQX | ||
| Z-0529-03 | Venus Eye Sphere 14 mm (Sterile) | Gulden Ophthalmics | HQX | ||
| Z-0528-03 | Venus Eye Sphere 12 mm (Sterile) | Gulden Ophthalmics | HQX | ||
| Z-0540-03 | Venus Eye sphere 10 mm (Sterile) | Gulden Ophthalmics | HQX | ||
| Z-1032-03 | Cathcor/LX/Desktop, System, X-Ray, Angiographic | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0976-03 | Magnetom Symphony/Sonata, OR Table. | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-0666-03 | Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035... | Boston Scientific Corporation | DQX | ||
| Z-0493-03 | Uroskop D1/D2/D3 - Table, Radiographic, Stationary Top. | Siemens Medical Solutions USA, Inc. | IXR | ||
| Z-0348-03 | OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm... | Bausch & Lomb Incorporated | LPM | ||
| Z-0496-03 | Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 ***... | Sorenson Medical, Inc. | BSY | ||
| Z-0343-03 | Philips HeartStart XL, Model M4735A Defibrillator/Monitor | Philips North America LLC | MKJ | ||
| Z-0346-03 | Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene... | Ssl Americas, Inc. | KGO | ||
| Z-0618-03 | Atakr II RF Power Generator, Models 4802 and 4803 | Medtronic, Inc. | DQY | ||
| Z-0437-03 | COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number... | Cook Incorporated | DYB | ||
| Z-0436-03 | COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number... | Cook Incorporated | DYB | ||
| Z-0435-03 | COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number... | Cook Incorporated | DYB | ||
| Z-0434-03 | COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number... | Cook Incorporated | DYB | ||
| Z-0433-03 | COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number... | Cook Incorporated | DYB | ||
| Z-0432-03 | COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number... | Cook Incorporated | DYB | ||
| Z-0431-03 | COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number... | Cook Incorporated | DYB | ||
| Z-0430-03 | COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number... | Cook Incorporated | DYB | ||
| Z-0429-03 | COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number... | Cook Incorporated | DYB |