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-2099-2015 | Class II | 0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra... | Stryker Corp. | JCX | |
| Z-1846-2015 | Class II | Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-2071-2015 | Class II | Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered... | Exactech, Inc. | KWQ | |
| Z-2070-2015 | Class II | Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System... | Exactech, Inc. | KWQ | |
| Z-1916-2015 | Class II | Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MAX | |
| Z-1821-2015 | Class II | Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in... | Unomedical A/S | FPA | |
| Z-1712-2015 | Class II | Oncentra Brachy radiation therapy planning software designed to analyze and plan... | Elekta Limited | MUJ | |
| Z-2054-2015 | Class II | Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1812-2015 | Class II | Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical... | Intuitive Surgical, Inc. | NAY | |
| Z-0132-2016 | Class II | One-Link Non-Dehp Y-Type Microbore Catheter Extension Set Needle-Free IV Connector with... | Baxter Healthcare Corporation | FPA | |
| Z-2093-2015 | Class II | NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery)... | Northern Digital Inc. | HAW | |
| Z-1814-2015 | Class II | MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 | CooperSurgical, Inc. | HDW | |
| Z-1827-2015 | Class II | NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-2487-2015 | Class II | Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1... | Horiba Instruments Incorporated | JBF | |
| Z-1842-2015 | Class II | VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK... | Remel Inc | MDB | |
| Z-1957-2015 | Class II | CentraLink" Data Management System; software is a network solution provider and... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-2207-2015 | Class II | ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500... | Siemens Healthcare Diagnostics Inc. | MMI | |
| Z-1841-2015 | Class II | VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK... | Remel Inc | MDB | |
| Z-1849-2015 | Class II | The VariSource iX series afterloader systems are computer controlled remote... | Varian Medical Systems, Inc. | JAQ | |
| Z-1829-2015 | Class II | Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set. | Varian Medical Systems, Inc. | JAQ | |
| Z-1727-2015 | Class II | Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and... | CooperSurgical, Inc. | LKF | |
| Z-1749-2015 | Class II | ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard... | Orthofix SRL | NKB | |
| Z-1697-2015 | Class II | ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X... | Coreva Health Science LLC | FRO | |
| Z-1699-2015 | Class I | M/L Taper with Kinectiv Technology. prosthesis, hip, semi-constrained (metal uncemented... | Zimmer GmbH | KWA | |
| Z-1732-2015 | Class II | ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and... | Edwards Lifesciences LLC | DXN | |
| Z-2768-2015 | Class II | MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml... | Horiba Instruments Incorporated | JJY | |
| Z-2406-2015 | Class II | Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor... | Veridex, LLC | NQI | |
| Z-1807-2015 | Class II | Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number... | Philips North America LLC | LLZ | |
| Z-1705-2015 | Class II | Syngo.via and Syngo.x ; a software solution intended to be used for viewing... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-1833-2015 | Class II | PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices... | ArthroCare Corporation | GEI | |
| Z-1832-2015 | Class II | EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices... | ArthroCare Corporation | GEI | |
| Z-1913-2015 | Class II | Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted... | Vascutek, Ltd. | MAL | |
| Z-1912-2015 | Class II | Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted... | Vascutek, Ltd. | MAL | |
| Z-1744-2015 | Class II | The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet... | Biomet France | KIH | |
| Z-1830-2015 | Class II | LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue... | Cook Incorporated | KGY | |
| Z-1809-2015 | Class I | Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI... | Teleflex Medical | BTM | |
| Z-1018-2017 | Class II | Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko... | The Binding Site Group Ltd. | JJE | |
| Z-2374-2015 | Class I | SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated... | Ethicon Endo-Surgery Inc | PDR | |
| Z-1840-2015 | Class III | The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The... | Bio-Rad Laboratories Inc. | JJX | |
| Z-1918-2015 | Class II | StoneLight 30 Laser System (NS3000). For use in surgical procedures using open... | New Star Lasers, Inc. | GEX | |
| Z-1711-2015 | Class II | 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm... | Synthes GmbH | HTW | |
| Z-1800-2015 | Class II | 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated... | Synthes GmbH | HWC | |
| Z-1718-2015 | Class II | Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction) | Advanced Back Technologies | ITH | |
| Z-1811-2015 | Class II | Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The... | CareFusion 303, Inc | FRN | |
| Z-1717-2015 | Class II | Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for... | Advanced Back Technologies | ITH | |
| Z-2363-2015 | Class II | ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number... | Howmedica Osteonics Corp | KWS | |
| Z-1801-2015 | Class II | T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE... | Teleflex Medical | FMI | |
| Z-1713-2015 | Class II | Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent... | Siemens Healthcare Diagnostics Inc. | GJT | |
| Z-1819-2015 | Class II | ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are... | Orthofix SRL | FZX | |
| Z-1725-2015 | Class II | Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect... | Abbott Medical | JJE |