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-2014-2023 | Class I | Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2013-2023 | Class I | Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2012-2023 | Class I | Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2011-2023 | Class I | Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2577-2023 | Class II | BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a... | PTW-Freiburg | IYE | |
| Z-2238-2023 | Class II | FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA... | Terumo Cardiovascular Systems Corporation | OUT | |
| Z-1169-2025 | Class II | Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20... | Murata Vios, Inc. | DRT | |
| Z-0141-2025 | Class I | GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1)... | GE Healthcare | FMZ | |
| Z-0140-2025 | Class I | GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant... | GE Healthcare | FMZ | |
| Z-2280-2023 | Class II | NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and... | Hamamatsu Corp. | PSY | |
| Z-2123-2023 | Class II | Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage... | Medtronic Sofamor Danek USA Inc | OVD | |
| Z-2122-2023 | Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF... | Medtronic Sofamor Danek USA Inc | OVD | |
| Z-2121-2023 | Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF... | Medtronic Sofamor Danek USA Inc | OVD | |
| Z-2120-2023 | Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF... | Medtronic Sofamor Danek USA Inc | OVD | |
| Z-2119-2023 | Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF... | Medtronic Sofamor Danek USA Inc | OVD | |
| Z-2118-2023 | Class II | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF... | Medtronic Sofamor Danek USA Inc | OVD | |
| Z-2117-2023 | Class II | Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF... | Medtronic Sofamor Danek USA Inc | OVD | |
| Z-2068-2023 | Class II | OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be... | Samsung HME America, Inc. | JAK | |
| Z-2036-2023 | Class II | Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord... | Medtronic Neuromodulation | LGW | |
| Z-2358-2023 | Class II | VITROS Immunodiagnostic Products Troponin I ES Calibrators | Ortho-Clinical Diagnostics, Inc. | MMI | |
| Z-2357-2023 | Class II | VITROS Immunodiagnostic Products Troponin I ES Reagent Pack | Ortho-Clinical Diagnostics, Inc. | MMI | |
| Z-2240-2023 | Class II | Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-2003-2023 | Class II | Design Options / Epidural anesthesia kit (10 count carton) | B Braun Medical Inc | OGE | |
| Z-2002-2023 | Class II | Perifix / Epidural anesthesia kit (10 count carton) | B Braun Medical Inc | OGE | |
| Z-2024-2023 | Class II | VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 | Luminex Corporation | OZN | |
| Z-2023-2023 | Class II | Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 | Luminex Corporation | PCH | |
| Z-2051-2023 | Class II | Exactech Ergo Impactor Handle, Catalog #321-09-05. | Exactech, Inc. | HWA | |
| Z-2050-2023 | Class II | Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. | Exactech, Inc. | OLO | |
| Z-2152-2023 | Class I | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers... | Datascope Corp. | DSP | |
| Z-2151-2023 | Class I | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers... | Datascope Corp. | DSP | |
| Z-2150-2023 | Class I | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers... | Datascope Corp. | DSP | |
| Z-2149-2023 | Class I | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers... | Datascope Corp. | DSP | |
| Z-2282-2023 | Class II | Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell... | Medtronic, Inc. | EOX | |
| Z-2145-2023 | Class II | Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A... | Beckman Coulter Biomedical GmbH | JJE | |
| Z-2144-2023 | Class II | Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ... | Beckman Coulter Biomedical GmbH | JJE | |
| Z-2001-2023 | Class I | MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery | Megadyne Medical Products, Inc | GEI | |
| Z-2478-2023 | Class II | epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW... | Siemens Healthcare Diagnostics Inc. | CHL | |
| Z-2477-2023 | Class II | epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor... | Siemens Healthcare Diagnostics Inc. | CHL | |
| Z-2476-2023 | Class II | epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor... | Siemens Healthcare Diagnostics Inc. | CHL | |
| Z-2000-2023 | Class I | MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during... | Megadyne Medical Products, Inc | GEI | |
| Z-1999-2023 | Class I | MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery | Megadyne Medical Products, Inc | GEI | |
| Z-1998-2023 | Class I | MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery | Megadyne Medical Products, Inc | GEI | |
| Z-1997-2023 | Class I | MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery | Megadyne Medical Products, Inc | GEI | |
| Z-1996-2023 | Class I | MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery | Megadyne Medical Products, Inc | GEI | |
| Z-1995-2023 | Class I | MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery | Megadyne Medical Products, Inc | GEI | |
| Z-1994-2023 | Class I | MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery | Megadyne Medical Products, Inc | GEI | |
| Z-0664-2025 | Class II | MICRO-X Rover Mobile X-ray System, # MXU-RV35 | Micro-X Ltd. | IZL | |
| Z-2236-2023 | Class II | Trexo Device | Trexo Robotics Holdings Inc. | IKK | |
| Z-2212-2023 | Class II | UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient... | UFSK - International OSYS GmbH | HME | |
| Z-2108-2023 | Class II | REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile | Osteomed | GWO |