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-0448-05 | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes... | Warsaw Orthopedic, Inc. | HWC | ||
| Z-0447-05 | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes... | Warsaw Orthopedic, Inc. | HWC | ||
| Z-0446-05 | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes... | Warsaw Orthopedic, Inc. | HWC | ||
| Z-0540-05 | UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3... | Plus Orthopedics | JWH | ||
| Z-0441-05 | Medtronic Midas Rex Legacy Telescoping Dissection Tool, Model TDQ-130D, manufactured by... | Medtronic Powered Surgical Solutions | GET | ||
| Z-0571-05 | Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action... | Maquet Cardiovascular Us Sales, LLC | CBK | ||
| Z-1154-2007 | ISOLOC Software Version 6.0, Part Number NT-NW-425-520. Localization software for... | Northwest Medical Physics Equipment, Inc. | IYE | ||
| Z-0220-05 | Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853... | GE Healthcare | JAA | ||
| Z-0219-05 | Proteus XR/a Radiographic X-ray System, models 2259973-1, 2259973-2, 2259973-3... | GE Healthcare | KPR | ||
| Z-0402-05 | Hill-Rom brand VersaCare Bed; product P3200. | Hill-Rom Inc. | FNL | ||
| Z-0401-05 | Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part... | Stryker Corp. | HWC | ||
| Z-0541-05 | The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual... | Diamedix Corp. | LHL | ||
| Z-0397-05 | HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare... | Baxter Healthcare Renal Div | FKX | ||
| Z-0611-05 | Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no... | Roche Diagnostics GmbH | |||
| Z-0610-05 | AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180... | Roche Diagnostics GmbH | |||
| Z-0609-05 | Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III... | Roche Diagnostics GmbH | |||
| Z-0608-05 | Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the... | Roche Diagnostics GmbH | |||
| Z-0607-05 | Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled... | Roche Diagnostics GmbH | |||
| Z-0606-05 | Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer Assembled... | Roche Diagnostics GmbH | |||
| Z-0553-05 | RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850... | Fisher & Paykel Healthcare, Inc. | BTT | ||
| Z-0640-05 | Xcelera R1.2 Cardiology image and information management solution software. | Philips North America LLC | LLZ | ||
| Z-0605-05 | Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled... | Roche Diagnostics GmbH | |||
| Z-0525-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0524-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0523-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0522-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0521-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0520-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0519-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0518-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0517-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0516-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0515-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0514-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0513-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0512-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0511-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0510-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0509-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0508-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0507-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0506-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0505-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0504-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0503-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0502-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0501-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0500-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0499-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction... | Cook Incorporated | MIH | ||
| Z-0498-05 | Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System... | Cook Incorporated | MIH |