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-0153-06 | Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a... | Baxter Healthcare Renal Div | KDI | ||
| Z-0061-06 | Baxter''s Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product... | Baxter Healthcare Corporation | LNX | ||
| Z-1601-05 | OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification... | Oasis Medical, Inc. | KYG | ||
| Z-1600-05 | OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification... | Oasis Medical, Inc. | KYG | ||
| Z-1599-05 | OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604... | Oasis Medical, Inc. | KYG | ||
| Z-0087-06 | Y-valve and T-valve, PSD/4 Syringe Drive Module parts. | Hamilton Co | JJC | ||
| Z-1595-05 | OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri... | Oasis Medical, Inc. | KYG | ||
| Z-0109-06 | Citation AT Femoral Stem | Howmedica Osteonics Corp | MAY | ||
| Z-0108-06 | Reliance PF Femoral Stem | Howmedica Osteonics Corp | MAY | ||
| Z-0107-06 | Meridian ST Femoral Stem | Howmedica Osteonics Corp | MAY | ||
| Z-0106-06 | Meridian PA Femoral Stem | Howmedica Osteonics Corp | MAY | ||
| Z-0030-06 | Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 56 mm... | Zimmer GmbH | KWS | ||
| Z-0029-06 | Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm... | Zimmer GmbH | KWS | ||
| Z-0028-06 | Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm... | Zimmer GmbH | KWS | ||
| Z-0027-06 | Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm... | Zimmer GmbH | KWS | ||
| Z-0026-06 | Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm... | Zimmer GmbH | KWS | ||
| Z-0025-06 | Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm... | Zimmer GmbH | KWS | ||
| Z-0024-06 | Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm... | Zimmer GmbH | KWS | ||
| Z-0023-06 | Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm... | Zimmer GmbH | KWS | ||
| Z-0165-06 | Biosteon brand HA/PLLA Cross Pin, Model Number 234-500-350; Product is distributed by... | Stryker Corp. | HWC | ||
| Z-0677-06 | Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma... | Abbott Medical | MGB | ||
| Z-0032-06 | VeriCal Calibrator Set | bioMerieux, Inc. | JPA | ||
| Z-0858-06 | GE Signa Advantage nuclear magnetic resonance imaging system. | GE Healthcare | LNH | ||
| Z-1567-05 | Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. | Datascope Corp. | DRT | ||
| Z-0068-06 | Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer... | Philips North America LLC | JAK | ||
| Z-0131-06 | Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is... | Tosoh Bioscience Inc | JPK | ||
| Z-2080-2008 | Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable... | Howmedica Osteonics Corp | JEC | ||
| Z-1568-05 | Bard * Davol Reliavac 400 Closed Wound Suction Kit * Sterile/EO * Single use *... | C.R. Bard Inc | GBX | ||
| Z-1592-05 | Epidural Infusion Pumps sold under the following labels; a) Baxter 6060E Epidural... | Baxter Healthcare Corporation | FRN | ||
| Z-1222-06 | IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S... | International Biophysics Corp. | DWE | ||
| Z-0894-06 | Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x... | Medtronic, Inc. | DXE | ||
| Z-1545-05 | Prisma continuous renal replacement system. | Gambro Renal Products | KDI | ||
| Z-1529-05 | Magnetom Espree. Magnetic Resonance Imaging System. model number 10018165 | Siemens Medical Solutions USA, Inc. | LNN | ||
| Z-1528-05 | Magnetom Avanto. Magnetic Resonance Imaging System. Model number 7391167 | Siemens Medical Solutions USA, Inc. | LNN | ||
| Z-0062-06 | INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX... | Event Medical Ltd | CBK | ||
| Z-0060-06 | T2 Recon Nail System. | Howmedica Osteonics Corp | HSB | ||
| Z-0059-06 | Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R... | Howmedica Osteonics Corp | JWH | ||
| Z-0058-06 | Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L... | Howmedica Osteonics Corp | JWH | ||
| Z-0122-2007 | Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990 | Boston Scientific Corporation | KRA | ||
| Z-1440-05 | Aqueduct Hematology Workflow Manager, software | Siemens Healthcare Diagnostics Inc. | JQP | ||
| Z-0161-06 | DePuy Mitek Straightshot Ligament Graft Passer/Protector, 11.5 mm Catalog Number : 232220 | DePuy Mitek, Inc. | LXH | ||
| Z-1588-05 | product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting... | Pascal International, Inc. | MED | ||
| Z-0794-2010 | Navigation Reamer T-handle; Non Sterile; Howmedica Osteonics, 325 Corporate Drive... | Howmedica Osteonics Corp | HTO | ||
| Z-0793-2010 | Reamer T-Handle; Non- Sterile; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ... | Howmedica Osteonics Corp | HTO | ||
| Z-1540-05 | VersaTREK Myco AS. | Trek Diagnostic Systems, Ltd. | MDB | ||
| Z-0557-06 | The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0... | Diasorin Inc. | LJY | ||
| Z-1586-05 | Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems | Abbott Vascular | FGE | ||
| Z-0057-06 | Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S... | Biosense Webster Inc | LPB | ||
| Z-1399-05 | ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs... | Abbott Medical | JHI | ||
| Z-1400-05 | Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100 | Abbott Medical | JIX |