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-1589-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8518, Size 9, 4 boxes... | Ansell Healthcare Products LLC | KGO | ||
| Z-1588-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8517, Size 8 1/2, 4... | Ansell Healthcare Products LLC | KGO | ||
| Z-1587-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8516, Size 8, 4 boxes... | Ansell Healthcare Products LLC | KGO | ||
| Z-1586-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8515, Size 7 1/2, 4... | Ansell Healthcare Products LLC | KGO | ||
| Z-1585-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8514, Size 7, 4 boxes... | Ansell Healthcare Products LLC | KGO | ||
| Z-1584-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8513, Size 6 1/2, 4... | Ansell Healthcare Products LLC | KGO | ||
| Z-1583-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8512, Size 6, 4 boxes... | Ansell Healthcare Products LLC | KGO | ||
| Z-1481-2009 | Zimmer Steinmann Pins, 7/64 in. (2.8 mm) diameter, 9 in. (229mm) length, style 6... | Zimmer GmbH | HTY | ||
| Z-1443-2009 | Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and... | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-1442-2009 | Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and... | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-1441-2009 | Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and... | Siemens Medical Solutions USA, Inc. | JAA | ||
| Z-1440-2009 | Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and... | Siemens Medical Solutions USA, Inc. | JAA | ||
| Z-1439-2009 | Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and... | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-1438-2009 | Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and... | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-1437-2009 | Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and... | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-1538-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 230 mm... | Zimmer GmbH | LXT | ||
| Z-1537-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 4.5 mm diameter, 230 mm... | Zimmer GmbH | LXT | ||
| Z-1536-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 195 mm... | Zimmer GmbH | LXT | ||
| Z-1535-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm... | Zimmer GmbH | LXT | ||
| Z-1534-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 3.0 mm diameter, 180 mm... | Zimmer GmbH | LXT | ||
| Z-1533-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 2.5 mm diameter, 180 mm... | Zimmer GmbH | LXT | ||
| Z-1532-2009 | TransFx External Fixation System Drill Bit, Quick Connect, 2.0 mm diameter, 125 mm... | Zimmer GmbH | LXT | ||
| Z-0349-2011 | ViewSonic 19" flat panel LCD display Model VG930M which is used as part of the Welch... | Welch Allyn Protocol, Inc. | DSI | ||
| Z-1612-2009 | Stryker Mantis Rod Inserter Inner Shaft; Non Sterile; Manufactured by Stryker Spine SAS... | Howmedica Osteonics Corp | MNH | ||
| Z-1611-2009 | Stryker Mantis Rod Inserter; Non Sterile, Manufactured by Stryker Spine SAS, Cestas... | Howmedica Osteonics Corp | MNH | ||
| Z-1488-2009 | BD 20 ml Syringe Luer-Lok Tip Sterile, Do not reuse; Catalog Number 309661. | Becton Dickinson & Co | FMF | ||
| Z-1645-2009 | Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100... | Kimberly-Clark Corporation | LYZ | ||
| Z-1646-2009 | Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001. | Disetronic Medical Systems | LZG | ||
| Z-0086-2010 | Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head. | Ortho Development Corp. | KWY | ||
| Z-1477-2009 | Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral... | Zimmer GmbH | JWH | ||
| Z-1644-2009 | Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and... | Alcon Laboratories | NGY | ||
| Z-1643-2009 | Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy... | Alcon Laboratories | NGY | ||
| Z-1246-2009 | Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument... | Zimmer GmbH | HTQ | ||
| Z-0010-2010 | Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number... | Alere San Diego, Inc. | DKZ | ||
| Z-0009-2010 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent... | Alere San Diego, Inc. | DKZ | ||
| Z-0008-2010 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product... | Alere San Diego, Inc. | DKZ | ||
| Z-0007-2010 | Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number... | Alere San Diego, Inc. | DKZ | ||
| Z-0006-2010 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent... | Alere San Diego, Inc. | DKZ | ||
| Z-1945-2009 | Maxilift Patient Lift, Non-AC Powered; a patient lift with a four point tilting frame... | Arjohuntleigh AB | FSA | ||
| Z-1568-2009 | Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. Model... | Philips North America LLC | KPS | ||
| Z-1391-2009 | Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in... | Alere San Diego, Inc. | MMI | ||
| Z-1452-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic... | Medtronic, Inc. | KGO | ||
| Z-1451-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic... | Medtronic, Inc. | KGO | ||
| Z-1450-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic... | Medtronic, Inc. | KGO | ||
| Z-1449-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic... | Medtronic, Inc. | KGO | ||
| Z-1448-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic... | Medtronic, Inc. | KGO | ||
| Z-1447-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic... | Medtronic, Inc. | KGO | ||
| Z-1446-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic... | Medtronic, Inc. | KGO | ||
| Z-1445-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic... | Medtronic, Inc. | KGO | ||
| Z-2325-2009 | ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System... | Abbott Medical | JJE |