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-2052-2008 | Bausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 60 Degree, REF MVS1601A... | Bausch & Lomb Incorporated | NKX | ||
| Z-2051-2008 | Bausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 15 Degree, REF MVS... | Bausch & Lomb Incorporated | NKX | ||
| Z-2050-2008 | Bausch & Lomb Millenium Phacoemulsification Needles, Needle Microflow 2.2 30 Degree, REF... | Bausch & Lomb Incorporated | NKX | ||
| Z-2049-2008 | Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip Angled 30 Degree... | Bausch & Lomb Incorporated | NKX | ||
| Z-2048-2008 | Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 30 Degree, REF... | Bausch & Lomb Incorporated | NKX | ||
| Z-2047-2008 | Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 15 Degree, REF... | Bausch & Lomb Incorporated | NKX | ||
| Z-2046-2008 | Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 45 Degree, REF... | Bausch & Lomb Incorporated | NKX | ||
| Z-2045-2008 | Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 30 Degree, REF... | Bausch & Lomb Incorporated | NKX | ||
| Z-2044-2008 | Bausch & Lomb Millennium Phacoemulsification Needles, Needle Tapered Hub 15 Degree, REF... | Bausch & Lomb Incorporated | NKX | ||
| Z-1775-2008 | Hall Easy-Fit Prosthetic Heart Valve - Mitral M7700. The device uses a single pyrolytic... | Medtronic Heart Valve Division | |||
| Z-1774-2008 | Hall Easy-Fit Prosthetic Heart Valve - Aortic A7700. The device uses a single pyrolytic... | Medtronic Heart Valve Division | |||
| Z-1704-2008 | Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter... | Biosense Webster Inc | DRF | ||
| Z-1703-2008 | Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter... | Biosense Webster Inc | DRF | ||
| Z-1877-2008 | PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive... | Integra LifeSciences Corporation | HSB | ||
| Z-1606-2008 | Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens... | Siemens Healthcare Diagnostics Inc. | MTF | ||
| Z-1549-2008 | Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use... | Abbott Medical | LHI | ||
| Z-1593-2008 | PathFinder Spinal Fixation System T-Handle Driver; Part 2151-7 (13" shaft); Non-sterile... | Spinal Concepts, Inc. | MNI | ||
| Z-1592-2008 | InCompass Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft) and 2151-5... | Spinal Concepts, Inc. | MNI | ||
| Z-1374-2008 | Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for... | Philips North America LLC | IZI | ||
| Z-1767-2008 | Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one... | Siemens Medical Solutions USA, Inc. | IYO | ||
| Z-1766-2008 | ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-1692-2008 | Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802... | Medtronic, Inc. | CBK | ||
| Z-0870-2008 | Roche/Hitachi Modular Analytics System Modular P Module GMMI immunoassay analyzer... | Roche Diagnostics GmbH | JJE | ||
| Z-0869-2008 | Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical chemistry... | Roche Diagnostics GmbH | JJE | ||
| Z-0868-2008 | Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer... | Roche Diagnostics GmbH | JJE | ||
| Z-0867-2008 | Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry... | Roche Diagnostics GmbH | JJE | ||
| Z-1684-2008 | Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with... | Diamedix Corp. | MST | ||
| Z-0866-2008 | Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical chemistry... | Roche Diagnostics GmbH | JJE | ||
| Z-1545-2008 | Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe... | Medefil, Inc. | NZW | ||
| Z-1544-2008 | Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe... | Medefil, Inc. | NZW | ||
| Z-1543-2008 | Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe... | Medefil, Inc. | NZW | ||
| Z-1872-2008 | Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810... | Biomet Microfixation | JEY | ||
| Z-1646-2008 | i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private... | Dental Imaging Technologies Corporation | MUH | ||
| Z-1645-2008 | i-CAT Classic 3D Dental Imaging System | Dental Imaging Technologies Corporation | JAK | ||
| Z-1568-2008 | 3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply 1251 Chemical Indicator... | 3M Company | JOJ | ||
| Z-1441-2010 | Elekta Synergy Intended to be used for radiation therapy treatment of malignant... | Elekta Limited | IYE | ||
| Z-1691-2008 | X-Celerate Universal Block Pegless Size #3, Non Sterile; | Howmedica Osteonics Corp | LXH | ||
| Z-1690-2008 | Universal Notch Preparation Guide, Size #3; Non Sterile; Howmedica Osteonics Corp. 325... | Howmedica Osteonics Corp | LXH | ||
| Z-1589-2008 | VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500... | Bio-Rad Laboratories Inc. | JPD | ||
| Z-1588-2008 | VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0019 (250... | Bio-Rad Laboratories Inc. | JPD | ||
| Z-1635-2008 | Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791 | Integra Pain Management | FMF | ||
| Z-1902-2008 | Levitronix CentriMag Back-Up Console Article Number: 201-30200; extracorporeal blood... | Levitronix, LLC | KFM | ||
| Z-1901-2008 | Levitronix CentriMag Primary System, Article Number: 201-30100; extracorporeal blood... | Levitronix, LLC | KFM | ||
| Z-1634-2008 | 6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L, Part Number: 1001970-06... | Abbott Vascular | DQY | ||
| Z-1633-2008 | 6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number... | Abbott Vascular | DQY | ||
| Z-1934-2009 | Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot... | Edwards Lifesciences LLC | KRA | ||
| Z-2197-2008 | CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical... | Merit Medical Systems, Inc. | KDD | ||
| Z-1642-2008 | AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is... | Philips North America LLC | IXI | ||
| Z-1327-2009 | Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro... | Sekisui Diagnostics P.E.I. Inc. | JMO | ||
| Z-1658-2008 | Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the... | Zimmer GmbH | KWT |