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-3120-2017 | Class II | Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended... | Leica Biosystems Richmond, Inc. | NJT | |
| Z-0400-2018 | Class II | MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic... | Medtronic, Inc. | NVZ | |
| Z-0399-2018 | Class II | MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient... | Medtronic, Inc. | NVZ | |
| Z-0615-2018 | Class II | Video Cystoscope models ECY-1570 and ECY-1570K | PENTAX of America, Inc. | FAJ | |
| Z-0507-2018 | Class II | The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic... | Microline Surgical, Inc | GEI | |
| Z-3137-2017 | Class II | Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary... | Medtronic Ireland | LOX | |
| Z-3136-2017 | Class II | Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary... | Medtronic Ireland | LOX | |
| Z-3238-2017 | Class II | BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an... | Bomimed Inc | CCW | |
| Z-0202-2018 | Class II | CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850... | GE Medical Systems Information Technologies, Inc. | MHX | |
| Z-2869-2017 | Class II | Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b)... | In2Bones SAS | HRS | |
| Z-0052-2018 | Class II | THERMI250 Radiofrequency System. Intended to provide heating for the purpose of... | Bios S.r.l. | PBX | |
| Z-0594-2018 | Class II | CORAIL HIGH OFFSET STEM Collarless SIZE 14 | Depuy Orthopaedics Inc. | KWL | |
| Z-0593-2018 | Class II | CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 | Depuy Orthopaedics Inc. | KWL | |
| Z-0489-2018 | Class I | MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product... | Philips North America LLC | MKJ | |
| Z-3076-2017 | Class II | VITEK 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R... | bioMerieux, Inc. | LON | |
| Z-3075-2017 | Class II | VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed... | bioMerieux, Inc. | LON | |
| Z-0403-2018 | Class II | Brilliance iCT - Model 728306 Computed Tomography X-ray systems | Philips North America LLC | JAK | |
| Z-0402-2018 | Class II | Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray... | Philips North America LLC | JAK | |
| Z-0603-2018 | Class II | Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool | Exactech, Inc. | OLO | |
| Z-2760-2017 | Class II | Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray... | Evident Scientific MIS, Inc. | RBY | |
| Z-0807-2018 | Class III | VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor... | Ortho-Clinical Diagnostics, Inc. | JJY | |
| Z-0486-2018 | Class II | Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FMI | |
| Z-0616-2018 | Class III | Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and... | Ameda, Inc. | HGX | |
| Z-3210-2017 | Class II | Implant,1-Pc,ang,3.0x10mm, Ref Zop30a10; Implant, 1-Pc, Ang, 3.0X11.5mm, Ref... | ZimVie US Corp LLC | DZE | |
| Z-3209-2017 | Class II | Waxing Coping, Cont 3.5 Mm,ang, Ref Zocwax3a; Waxing Coping, Cont 3.5 Mm, Ref... | ZimVie US Corp LLC | NDP | |
| Z-3208-2017 | Class II | Impression Cap Cont 3.5Mm, Ref Zocimp3a; Mpression Cap Cont 3.5Mm, Ref... | ZimVie US Corp LLC | NDP | |
| Z-3207-2017 | Class II | Try-In,abutment, Cont, 3.5X4.5, Ref Zoat34; Try-in, Abutment, Cont, 4.5X5.5, Ref... | ZimVie US Corp LLC | NDP | |
| Z-3206-2017 | Class II | Abut Gold Friction-Fit, Ref Hla3g; Abut Gold Friction-Fit, Ref Hla4g; Coping Gold Eng... | ZimVie US Corp LLC | DZE | |
| Z-3205-2017 | Class II | Thread Retrieval Drill Ref 2224 | ZimVie US Corp LLC | DZA | |
| Z-3204-2017 | Class II | Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide... | ZimVie US Corp LLC | NDP | |
| Z-1782-2018 | Class II | Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered... | Ondamed Inc | HCC | |
| Z-0351-2018 | Class II | Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880 | Hologic, Inc. | OIJ | |
| Z-0325-2018 | Class II | Mac Pin Non-Cannulated Screw, 6.5 x 60mm | Spinal Elements, Inc | NKB | |
| Z-0316-2018 | Class II | Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling... | Spinal Elements, Inc | OVE | |
| Z-3112-2017 | Class II | Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number... | Qualigen Inc | MRG | |
| Z-3077-2017 | Class II | Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The... | Edwards Lifesciences LLC | DXE | |
| Z-0315-2018 | Class II | SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold... | Centurion Medical Products, LP | FMI | |
| Z-0499-2018 | Class II | Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number... | Roche Diagnostics GmbH | JJE | |
| Z-0498-2018 | Class II | cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973... | Roche Diagnostics GmbH | JJE | |
| Z-0387-2018 | Class II | Phadia 1000 Instrument, Article Number 12-3800-01. | Phadia AB | DHB | |
| Z-0349-2018 | Class II | Persona Partial Knee System, Size 8, Finishing Guide | Zimmer GmbH | HSX | |
| Z-0687-2018 | Class II | Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*... | Boston Scientific Neuromodulation Corporation | GXI | |
| Z-3212-2017 | Class II | LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b)... | Teleflex Medical | CCT | |
| Z-0291-2018 | Class II | Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and... | Orthofix SRL | KTT | |
| Z-3041-2017 | Class II | HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The... | Baxter Healthcare Corporation | FKX | |
| Z-3040-2017 | Class II | HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The... | Baxter Healthcare Corporation | FKX | |
| Z-0206-2018 | Class II | Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The... | Novo Nordisk a/S | FMF | |
| Z-3104-2017 | Class II | JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the... | Stanmore Implants Worldwide, Ltd. | KRO | |
| Z-1495-2018 | Class II | Beijing Syntech Laser UL Station surgical lasers | Beijing Syntech Laser Co., Ltd | GEX | |
| Z-1494-2018 | Class II | Beijing Syntech Laser Nice Station Light Based Platform surgical lasers | Beijing Syntech Laser Co., Ltd | GEX |