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-1124-2009 | Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782L... | Medtronic Neurosurgery | JXG | ||
| Z-1398-2009 | Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number... | Abbott Medical | GKZ | ||
| Z-2327-2009 | DCL (Diagnostic Chemicals Limited) Creatine Start Reagent(R1) Catalog Number: 265-OP. | Sekisui Diagnostics P.E.I. Inc. | JFY | ||
| Z-2326-2009 | DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number... | Sekisui Diagnostics P.E.I. Inc. | JFY | ||
| Z-1206-2009 | Zoll AED Plus Defibrillator | ZOLL Medical Corporation | MKJ | ||
| Z-0578-2010 | Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation. | Ellex Medical Pty Ltd | HQF | ||
| Z-0577-2010 | Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for... | Ellex Medical Pty Ltd | HQF | ||
| Z-1503-2009 | Arrow Peripherally Inserted Central Catheter | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | ||
| Z-1502-2009 | Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts | Arrow International LLC (subsidiary of Teleflex Incorporated) | DXE | ||
| Z-1501-2009 | Arrow Percutaneous Thrombolytic Device (PTD) for fistula and dialysis grafts | Arrow International LLC (subsidiary of Teleflex Incorporated) | MCW | ||
| Z-1500-2009 | Arrow Balloon and stylet temporary pacing catheter | Arrow International LLC (subsidiary of Teleflex Incorporated) | LDF | ||
| Z-1499-2009 | Arrow ARROWg+ard CVCs (Central Venous Catheters) | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | ||
| Z-1498-2009 | Arrow ARROWg+ard Blue Plus Multi-Lumen CVCs (Central Venous Catheters) | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | ||
| Z-1497-2009 | Arrow ARROWg+ard Quad-Lumen CVCs (Central Venous Catheters) | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | ||
| Z-1496-2009 | Arrow Two-Lumen Central Venous Access (MAC) | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | ||
| Z-1495-2009 | Arrow Multi-Lumen CVC w/ BlueFlex Tip (Central Venous Catheter) | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | ||
| Z-1494-2009 | Arrow Single Lumen CVCs (Central Venous Catheters) | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | ||
| Z-1493-2009 | Arrow Percutaneous Sheath Introducers | Arrow International LLC (subsidiary of Teleflex Incorporated) | KGZ | ||
| Z-1492-2009 | Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | ||
| Z-1491-2009 | Arrow Super Arrow-Flex Percutaneous Sheath Introducers | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | ||
| Z-1490-2009 | Arrow Extension sets and accessories for intravascular use. | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1489-2009 | Arrow 4way Hi-Flo Stopcock with male luer lock, latex free used in various IV kits. | Arrow International LLC (subsidiary of Teleflex Incorporated) | FPA | ||
| Z-1194-2009 | Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard... | Stryker Corp. | FRN | ||
| Z-1193-2009 | Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5 per box, sterile... | Stryker Corp. | FRN | ||
| Z-1192-2009 | Stryker PainPump2, 250 mL PainPump with 5.0 inch ExFen 2-Site Catheter Set, 5 per box... | Stryker Corp. | FRN | ||
| Z-1191-2009 | Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-Site Catheter Set, 5 per box... | Stryker Corp. | FRN | ||
| Z-1190-2009 | Stryker PainPump2, 250 mL Pre-Set PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and... | Stryker Corp. | FRN | ||
| Z-1189-2009 | Stryker PainPump2, 250 mL Pre-Set PainPump with Luer Lock Tubing Set, 2.5 inch ExFen and... | Stryker Corp. | FRN | ||
| Z-1188-2009 | Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard... | Stryker Corp. | FRN | ||
| Z-1187-2009 | Stryker PainPump2, 400 mL PainPump with 5.0 inch ExFen 2 Site Catheter Set, 5 per box... | Stryker Corp. | FRN | ||
| Z-1186-2009 | Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2 Site Catheter Set, 5 per box... | Stryker Corp. | FRN | ||
| Z-1185-2009 | Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 5 per box, sterile... | Stryker Corp. | FRN | ||
| Z-1184-2009 | Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen Catheter and Luer Lock Tubing Set... | Stryker Corp. | FRN | ||
| Z-1183-2009 | Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard... | Stryker Corp. | FRN | ||
| Z-1182-2009 | Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 2.5 inch ExFen and Standard... | Stryker Corp. | FRN | ||
| Z-1670-2009 | DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF... | DePuy Spine, Inc. | KWP | ||
| Z-1348-2009 | Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use... | Synthes GmbH | ODP | ||
| Z-2348-2010 | NFlex Stabilization System 150mm The Synthes N-Hance and NFix II rods are intended to... | Synthes GmbH | NQP | ||
| Z-2347-2010 | NFlex Straight monosegmental L 150mm The Synthes N-Hance and NFix II rods are intended to... | Synthes GmbH | NQP | ||
| Z-2346-2010 | NFix II System 150mm The Synthes N-Hance and NFix II rods are intended to provide... | Synthes GmbH | NQP | ||
| Z-2345-2010 | N-Hance System 150mm The Synthes N-Hance and NFix II rods are intended to provide... | Synthes GmbH | NQP | ||
| Z-2344-2010 | TI N-Hance Rod 150mm Sterile The Synthes N-Hance and NFix II rods are intended to provide... | Synthes GmbH | NQP | ||
| Z-1324-2009 | Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in... | Synthes GmbH | KTT | ||
| Z-1266-2009 | syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-1243-2009 | Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter with AMC... | Edwards Lifesciences LLC | DYG | ||
| Z-1242-2009 | Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter For use with... | Edwards Lifesciences LLC | DYG | ||
| Z-1241-2009 | Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2 Thermodilution Catheter with AMC... | Edwards Lifesciences LLC | DYG | ||
| Z-1240-2009 | Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD (An... | Edwards Lifesciences LLC | KRA | ||
| Z-1239-2009 | Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC... | Edwards Lifesciences LLC | KRA | ||
| Z-1238-2009 | Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75 For use inpatients... | Edwards Lifesciences LLC | KRA |