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-0640-2014 | Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle... | Ansell Sandel Medical Solutions LLC | GDZ | |
| Z-0639-2014 | Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with... | Ansell Sandel Medical Solutions LLC | GDZ | |
| Z-0638-2014 | Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with... | Ansell Sandel Medical Solutions LLC | GDZ | |
| Z-0637-2014 | Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle... | Ansell Sandel Medical Solutions LLC | GDZ | |
| Z-0636-2014 | Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with... | Ansell Sandel Medical Solutions LLC | GDZ | |
| Z-0635-2014 | Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with... | Ansell Sandel Medical Solutions LLC | GDZ | |
| Z-0905-2014 | Class II | Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357... | Medtronic Navigation, Inc | GEI | |
| Z-0477-2014 | Class II | Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle... | Zimmer GmbH | HSN | |
| Z-0476-2014 | Class II | Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle... | Zimmer GmbH | HSN | |
| Z-0475-2014 | Class II | Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle... | Zimmer GmbH | HSN | |
| Z-0629-2014 | Class II | Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-0453-2014 | Class II | Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller)... | Sunrise Medical, Inc. | IOR | |
| Z-0436-2014 | Class II | Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical... | Intuitive Surgical, Inc. | NAY | |
| Z-0403-2014 | Class II | STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature... | Advanced Sterilization Products | MLR | |
| Z-0402-2014 | Class II | STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low... | Advanced Sterilization Products | MLR | |
| Z-1259-2015 | Class II | Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | |
| Z-1831-2014 | Class II | Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components... | Siemens Healthcare Diagnostics Inc. | JCB | |
| Z-1830-2014 | Class II | Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components... | Siemens Healthcare Diagnostics Inc. | JCB | |
| Z-0804-2014 | Class II | Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic... | GE Healthcare | JAA | |
| Z-0607-2014 | Class II | IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL... | Baxter Healthcare Corporation | NEP | |
| Z-1829-2014 | Class II | UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-1828-2014 | Class II | UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0578-2014 | Class II | ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only... | Materialise USA, LLC. | ||
| Z-0577-2014 | Class II | ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only... | Materialise USA, LLC. | ||
| Z-0843-2014 | Class II | API NH (REF 10400) API NH is a standardized system for the identification of Neisseria... | bioMerieux, Inc. | ||
| Z-0842-2014 | Class II | API Listeria (REF 10300) API Listeria is a standardized system for the identification of... | bioMerieux, Inc. | ||
| Z-0841-2014 | Class II | ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results... | bioMerieux, Inc. | ||
| Z-0550-2014 | Class II | FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for... | Qualigen Inc | MRG | |
| Z-0549-2014 | Class II | FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free... | Qualigen Inc | CEC | |
| Z-0548-2014 | Class II | FastPack Testosterone Immunoassay Chemilunescence assay for the determination of... | Qualigen Inc | CDZ | |
| Z-0547-2014 | Class II | FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total... | Qualigen Inc | LTJ | |
| Z-0471-2014 | Class II | Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0470-2014 | Class II | Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0450-2014 | Class II | SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No... | CareFusion 303, Inc | FPA | |
| Z-0435-2014 | Class II | VersaSafe Extension Set, Model No. 21000M-007 | CareFusion 303, Inc | FPA | |
| Z-0725-2014 | Class II | GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems... | GE Healthcare | IZL | |
| Z-0849-2014 | Class II | Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232... | Howmedica Osteonics Corp | HSB | |
| Z-0579-2014 | Class II | OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL... | Orthopediatrics Corp | MBI | |
| Z-0529-2014 | Class II | EOS System X- ray beam Digital radiography system used in general radiographic... | EOS imaging | MQB | |
| Z-0940-2014 | Class II | Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0465-2014 | Class II | Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use... | Karl Storz Endoscopy-America, Inc. | GCJ | |
| Z-0348-2014 | Class II | Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use... | Candela Corporation | GEX | |
| Z-0571-2014 | Class II | Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100... | Data Innovations, LLC | JQP | |
| Z-0569-2014 | Class II | IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests)... | Siemens Healthcare Diagnostics Inc. | CGN | |
| Z-0545-2014 | Class II | SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a... | ASI Medical, Inc. | EIA | |
| Z-0592-2014 | Class II | Tib Nail | Zimmer GmbH | HSB | |
| Z-0591-2014 | Class II | Fem Cond Buttress Plt, Lt | Zimmer GmbH | HRS | |
| Z-0590-2014 | Class II | NGK Stem Ext 24 x 245mm | Zimmer GmbH | JWH | |
| Z-0589-2014 | Class II | Itst Threaded Guide Pin | Zimmer GmbH | FZX | |
| Z-0442-2014 | Class II | Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF... | Boston Scientific Corporation | FED |