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-2130-2018 | Class II | L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number)... | Orthofix SRL | HRS | |
| Z-2129-2018 | Class II | Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right... | Orthofix SRL | HRS | |
| Z-2128-2018 | Class II | H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM... | Orthofix SRL | HRS | |
| Z-2127-2018 | Class II | Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM... | Orthofix SRL | HRS | |
| Z-2126-2018 | Class II | CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small... | Orthofix SRL | HRS | |
| Z-2125-2018 | Class II | Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM... | Orthofix SRL | HRS | |
| Z-2124-2018 | Class II | Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D... | Orthofix SRL | HRS | |
| Z-2123-2018 | Class II | Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)... | Orthofix SRL | HRS | |
| Z-2122-2018 | Class II | Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D... | Orthofix SRL | HRS | |
| Z-2121-2018 | Class II | Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size... | Orthofix SRL | HRS | |
| Z-2120-2018 | Class II | Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size... | Orthofix SRL | HRS | |
| Z-2119-2018 | Class II | Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number)... | Orthofix SRL | HRS | |
| Z-2118-2018 | Class II | Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number... | Orthofix SRL | HRS | |
| Z-2117-2018 | Class II | Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX... | Orthofix SRL | HRS | |
| Z-2116-2018 | Class II | Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only... | Orthofix SRL | HRS | |
| Z-1705-2018 | Class II | Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation... | Zimmer GmbH | JEY | |
| Z-1882-2018 | Class II | Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision... | Visaris d.o.o. | KPR | |
| Z-1881-2018 | Class II | Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision... | Visaris d.o.o. | KPR | |
| Z-1774-2018 | Class I | Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT... | Abbott Medical | DSQ | |
| Z-1880-2018 | Class II | Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision... | Visaris d.o.o. | KPR | |
| Z-0797-2019 | Class II | Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing... | Handpiece Headquarters | EBZ | |
| Z-1530-2018 | Class II | CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH... | Menarini Silicon Biosystems Inc. | NQI | |
| Z-1645-2018 | Class II | IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are... | IMRIS Imaging, Inc. | LNH | |
| Z-1642-2018 | Class II | CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product... | MAQUET CARDIOPULMONARY GmbH | KRI | |
| Z-1667-2018 | Class II | Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6)... | Baxter Healthcare Corporation | FRN | |
| Z-1666-2018 | Class II | Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6)... | Baxter Healthcare Corporation | FRN | |
| Z-1665-2018 | Class II | Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6)... | Baxter Healthcare Corporation | FRN | |
| Z-1664-2018 | Class II | Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6)... | Baxter Healthcare Corporation | FRN | |
| Z-1663-2018 | Class II | Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6)... | Baxter Healthcare Corporation | FRN | |
| Z-2136-2018 | Class II | cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully... | Roche Diagnostics GmbH | JJE | |
| Z-1522-2018 | Class II | Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number... | Zimmer GmbH | HSB | |
| Z-2541-2018 | Class II | PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100... | Bio-Rad Laboratories Inc. | JJE | |
| Z-2434-2018 | Class II | AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number... | Cardica, Inc. | FZP | |
| Z-2433-2018 | Class II | AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The... | Cardica, Inc. | FZP | |
| Z-2467-2018 | Class II | T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment... | GE Healthcare | IOL | |
| Z-2114-2018 | Class II | Bivona Tracheostomy Tube Tracheostomy Tubes | Abbott Medical | BTO | |
| Z-1759-2018 | Class II | Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630 | Synthes (USA) Products LLC | GAD | |
| Z-1758-2018 | Class II | Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623 | Synthes (USA) Products LLC | GAD | |
| Z-1538-2018 | Class II | Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint... | Zimmer GmbH | LPH | |
| Z-1537-2018 | Class II | Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer... | Zimmer GmbH | JDI | |
| Z-2527-2018 | Class II | MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE... | GE Healthcare | LNH | |
| Z-2409-2018 | Class II | Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The... | IMMY, Inc. | GMD | |
| Z-2256-2018 | Class II | C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a... | PENTAX of America, Inc. | GEH | |
| Z-2176-2018 | Class II | Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246... | Philips North America LLC | JAK | |
| Z-2175-2018 | Class II | Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed... | Philips North America LLC | JAK | |
| Z-2174-2018 | Class II | Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed... | Philips North America LLC | JAK | |
| Z-2605-2018 | Class II | Think Surgical Cutter, Flat, 6.2mm x 144mm. For use only with the TCAT Computer-Assisted... | Think Surgical Inc. | OLO | |
| Z-1907-2018 | Class II | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF... | Smith & Nephew, Inc. | JWH | |
| Z-1906-2018 | Class II | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121... | Smith & Nephew, Inc. | JWH | |
| Z-1905-2018 | Class II | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF... | Smith & Nephew, Inc. | JWH |