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-0997-2008 | Stryker 7.5 x 9.5 mm Acorn Bur, Extra long, sterile, Stryker Instruments, Kalamazoo, MI... | Stryker Corp. | HBE | ||
| Z-0996-2008 | Stryker 6.1 x 8.0 mm Acorn Bur, Extra long, sterile, Stryker Instruments, Kalamazoo, MI... | Stryker Corp. | HBE | ||
| Z-0995-2008 | Stryker 7.5 x 7.9 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo... | Stryker Corp. | HBE | ||
| Z-0994-2008 | Stryker 12.3 x 10.7 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo... | Stryker Corp. | HBE | ||
| Z-0993-2008 | Stryker 10.5 x 10.7 mm Fluted Drum, Extra Long, sterile, Stryker Instruments, Kalamazoo... | Stryker Corp. | HBE | ||
| Z-0992-2008 | Stryker 6.0 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill Extra Long... | Stryker Corp. | HBE | ||
| Z-0991-2008 | Stryker 4.7 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill Extra Long... | Stryker Corp. | HBE | ||
| Z-0990-2008 | Stryker Round Fluted Bur (9.1 mm) Extra Long for use with TPS Universal Drill Extra Long... | Stryker Corp. | HBE | ||
| Z-0989-2008 | Stryker Round Fluted Bur (7.6 mm) Extra Long for use with TPS Universal Drill Extra Long... | Stryker Corp. | HBE | ||
| Z-0988-2008 | Stryker Round Fluted Bur (6.0mm) Extra-Long for use with TPS Universal Drill Extra Long... | Stryker Corp. | HBE | ||
| Z-1106-2008 | Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for... | Stryker Corp. | JDZ | ||
| Z-1308-2008 | Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion... | Medtronic Neuromodulation | LKK | ||
| Z-1197-2009 | Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number... | Siemens Healthcare Diagnostics Inc. | LTJ | ||
| Z-2220-2009 | Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. The Access Hybritech... | Siemens Healthcare Diagnostics Inc. | MTG | ||
| Z-1132-2008 | Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008 | Keeler Instruments, Inc. | HLI | ||
| Z-1050-2008 | Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with... | Physio Control, Inc. | MKJ | ||
| Z-1604-2010 | Leksell GammaPlan 8.0 image fusion Leksell GammaPlan is designed for use with the... | Elekta Limited | IWB | ||
| Z-1189-2008 | Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic. | Bio-Rad Laboratories Inc. | |||
| Z-0915-2008 | BD 10 ml Syringe Luer Lok Tip, Reorder #3039605, BD, Franklin Lakes, NJ 07417. | Becton Dickinson & Co | FMF | ||
| Z-0914-2008 | BD 5 ml Syringe Luer Lok Tip Bulk Sterile Convenience Pak. Latex Free . Sterile. Reorder... | Becton Dickinson & Co | FMF | ||
| Z-1514-2008 | VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD)... | Boston Scientific Corporation | LWP | ||
| Z-1513-2008 | VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872 | Boston Scientific Corporation | LWP | ||
| Z-2730-2011 | Stainless Steel, Natural, Lower, .018": Arch Wires. Highland Metals, San Jose, CA 95125 | G & H Wire Company | D | ||
| Z-2729-2011 | Stainless Steel, Natural, Upper, .018": Arch Wires. Highland Metals, San Jose, CA 95125 | G & H Wire Company | D | ||
| Z-2728-2011 | Stainless Steel, Natural,Lower, .016 x.022: Arch Wires. Highland Metals, San Jose, CA... | G & H Wire Company | D | ||
| Z-2727-2011 | Stainless Steel, Progressive Lower, .016: Arch Wires. Intended for use in orthodontic... | G & H Wire Company | D | ||
| Z-1348-2008 | Da Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical System... | Intuitive Surgical, Inc. | NAY | ||
| Z-1141-2008 | iSite PACS image management system; Picture Archiving and Communications System... | Philips North America LLC | LLZ | ||
| Z-0987-2008 | AirLife Infant nCPAP System Driver (Catalog No: 006900;) a nasal continuous positive... | Medtronic, Inc. | BZD | ||
| Z-2406-2010 | Easy Diagnost DSI is a Easy Diagnost Digital Spot Imaging system. It has a capability to... | Philips North America LLC | IXR | ||
| Z-2405-2010 | EasyDiagnost Classic has a radiographic tilting table. This system has a cassette film... | Philips North America LLC | IXR | ||
| Z-2404-2010 | Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot. Intended... | Philips North America LLC | IXL | ||
| Z-0826-2008 | Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI | Xoran Technologies, LLC | JAK | ||
| Z-1460-2008 | Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model... | Varian Medical Systems, Inc. | KPQ | ||
| Z-1442-2008 | Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to... | Varian Medical Systems, Inc. | IYE | ||
| Z-1181-2008 | Hospira LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is... | Abbott Medical | MEA | ||
| Z-1883-2008 | GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE... | GE Healthcare | KPR | ||
| Z-1611-2008 | Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424, 2118104, 2157009... | GE Healthcare | IXR | ||
| Z-1610-2008 | GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495, 2336900... | GE Healthcare | JAA | ||
| Z-0881-2008 | PERFEKTUM TOOMEY EVACUATING SYRINGES, REF/Part # 5047, DESCRIPTION: 30CC LOCK TIP, RX... | Popper & Sons, Inc. | FMI | ||
| Z-0319-2011 | i-STAT BNP cartridge Abbott Point of Care, Princeton, NJ 08540 | Abbott Medical | CHL | ||
| Z-0318-2011 | i-STAT CK-MB cartridge Abbott Point of Care, Princeton, NJ 08540 | Abbott Medical | CHL | ||
| Z-0317-2011 | i-STAT cTnl cartridge Abbott Point of Care, Princeton, NJ 08540 | Abbott Medical | CHL | ||
| Z-1644-2008 | EVMS (Enterprise Visual Medical System); Picture archiving and communications system... | Merge Healthcare Incorporated | LLZ | ||
| Z-1104-2008 | GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare... | GE Healthcare | LLZ | ||
| Z-0933-2008 | Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model... | Solta Medical, Inc. | GEI | ||
| Z-1180-2008 | da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic... | Intuitive Surgical, Inc. | NAY | ||
| Z-0675-2008 | Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton... | Organogenesis, Inc. | MGR | ||
| Z-1351-2008 | Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3... | ELITechGroup Inc | JJM | ||
| Z-1350-2008 | Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials... | ELITechGroup Inc | JJM |