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-0882-2011 | Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0889-2011 | TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart... | Cardiac Assist, Inc | DWF | ||
| Z-1100-2012 | Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation... | Sybron Dental Specialties, Inc. | EMA | ||
| Z-0935-2011 | Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps... | Baxter Healthcare Corporation | FRN | ||
| Z-0931-2011 | Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FRN | ||
| Z-1867-2012 | Class II | BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product... | Siemens Healthcare Diagnostics Inc. | JPA | |
| Z-2838-2011 | "***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental... | ZimVie US Corp LLC | NSP | ||
| Z-1880-2011 | POUCH/CARTON LABEL: ***REF 5023-138***9.5 x 25.5 x 0.4mm***QTY 1***MICRO SAGITTAL... | Linvatec Corporation | HWE | ||
| Z-2033-2011 | Codman Plastic Disposable ICP Kit, Complete, Adult Product Code 80-1197 This is a single... | Cerenovus, Inc. | GWM | ||
| Z-2032-2011 | Codman Cranial Hand Drill Product Code: 82-6607 This is a single use, disposable drill... | Cerenovus, Inc. | GWM | ||
| Z-2031-2011 | Codman Plastic Disposable ICP Kit, Adult Product Code: 80-1196 This is a single use... | Cerenovus, Inc. | GWM | ||
| Z-2030-2011 | Codman Metal Disposable ICP Kit Product Code: 80-1190 This is a single use, disposable... | Cerenovus, Inc. | GWM | ||
| Z-2029-2011 | Ghajar Guide Ventriculostomy Kit Product Code: 80-1185 This is a single use, disposable... | Cerenovus, Inc. | GWM | ||
| Z-1244-2011 | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their... | Stryker Corp. | HBE | ||
| Z-1243-2011 | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their... | Stryker Corp. | HBE | ||
| Z-1242-2011 | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their... | Stryker Corp. | HBE | ||
| Z-1241-2011 | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their... | Stryker Corp. | HBE | ||
| Z-1240-2011 | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their... | Stryker Corp. | HBE | ||
| Z-1239-2011 | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their... | Stryker Corp. | HBE | ||
| Z-1238-2011 | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their... | Stryker Corp. | HBE | ||
| Z-1237-2011 | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their... | Stryker Corp. | HBE | ||
| Z-1236-2011 | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their... | Stryker Corp. | HBE | ||
| Z-1235-2011 | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their... | Stryker Corp. | HBE | ||
| Z-1234-2011 | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their... | Stryker Corp. | HBE | ||
| Z-1233-2011 | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their... | Stryker Corp. | HBE | ||
| Z-1232-2011 | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their... | Stryker Corp. | HBE | ||
| Z-1093-2011 | Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label... | Accriva Diagnostics, Inc. | KQG | ||
| Z-1739-2011 | Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 This method is an... | Siemens Healthcare Diagnostics Inc. | LCD | ||
| Z-2028-2011 | Codman Disposable Twist Drill Product code: 80-1200 This is a single use, disposable... | Cerenovus, Inc. | GWM | ||
| Z-0583-2012 | INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers... | Mallinckrodt Manufacturing LLC | MRN | ||
| Z-3001-2011 | Micro-Fuel Cell Oxygen Sensor, Class RI5 Sensor Part Number: C41131-R15 Teledyne... | Teledyne Analytical Instruments | |||
| Z-1654-2012 | PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to... | Apheresis Technologies, Inc. | FIR | ||
| Z-1941-2012 | Class II | Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat. | Pride Mobility Products Corp | INI | |
| Z-1473-2011 | GE ADVANTAGE SIM MD versions 5.x, 6.x, 7.x up to and including version 7.7.0 Advantage... | GE Healthcare | KPG | ||
| Z-1650-2011 | BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 The BioPlex 2200 Syphilis IgG... | Bio-Rad Laboratories Inc. | LIP | ||
| Z-1457-2011 | QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842 | Ortho-Clinical Diagnostics, Inc. | JHI | ||
| Z-0796-2011 | Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers... | Advanced Bionics LLC | MCM | ||
| Z-0795-2011 | Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers... | Advanced Bionics LLC | MCM | ||
| Z-1474-2011 | Aesculap MicroSpeed Uni Control Box, Part #GD670 Intended for high speed cutting, sawing... | Aesculap Inc | HBC | ||
| Z-2649-2017 | Class III | The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II... | Horiba Instruments Incorporated | JHW | |
| Z-0983-2012 | EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter... | Biosense Webster Inc | OAE | ||
| Z-0982-2012 | EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter... | Biosense Webster Inc | OAE | ||
| Z-0981-2012 | EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter... | Biosense Webster Inc | OAE | ||
| Z-0980-2012 | EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter... | Biosense Webster Inc | OAE | ||
| Z-0979-2012 | EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter... | Biosense Webster Inc | OAE | ||
| Z-2069-2011 | Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number... | Lockheed-Martin Aculight | RGB | ||
| Z-1066-2011 | Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry... | Abaxis Inc | CKA | ||
| Z-0844-2011 | Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7 | Fresenius Medical Care Renal Therapies Group, LLC | FJK | ||
| Z-0843-2011 | Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9 | Fresenius Medical Care Renal Therapies Group, LLC | FJK | ||
| Z-0955-2011 | Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1... | Integra LifeSciences Corporation | HRS |