Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | NanoZoomer S360MD Slide scanner system-automated system for creating, viewing... | If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the who... | Class II | Hamamatsu Corporation |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 5, 2023 | Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022... | Class II | Luminex Corporation |
| Jun 5, 2023 | Perifix¿ / Epidural anesthesia kit (10 count carton) | Kits were assembled with the incorrect Filter Straw. | Class II | B. Braun Medical, Inc. |
| Jun 5, 2023 | VITROS Immunodiagnostic Products Troponin I ES Calibrators | Reagent packs could potentially contain incorrect wells, which will generate incorrect, and poten... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Jun 5, 2023 | Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. | The ball and spring housed within the locking mechanism of the handle can dislodge during disasse... | Class II | Exactech, Inc. |
| Jun 5, 2023 | VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022... | Class II | Luminex Corporation |
| Jun 5, 2023 | Exactech Ergo Impactor Handle, Catalog #321-09-05. | The ball and spring housed within the locking mechanism of the handle can dislodge during disasse... | Class II | Exactech, Inc. |
| Jun 5, 2023 | Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operatin... | Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 5, 2023 | Design Options¿ / Epidural anesthesia kit (10 count carton) | Kits were assembled with the incorrect Filter Straw. | Class II | B. Braun Medical, Inc. |
| Jun 5, 2023 | VITROS Immunodiagnostic Products Troponin I ES Reagent Pack | Reagent packs could potentially contain incorrect wells, which will generate incorrect, and poten... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Jun 2, 2023 | Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytos... | Cell Collection Device may be at increased risk of the sponge detaching from the string during re... | Class II | Covidien, LLC |
| Jun 2, 2023 | Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 1... | A software defect in the DxA Automation System may cause tests to be run on patient samples in tu... | Class II | Beckman Coulter Biomedical GmbH |
| Jun 2, 2023 | Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240... | A software defect in the DxA Automation System may cause tests to be run on patient samples in tu... | Class II | Beckman Coulter Biomedical GmbH |
| Jun 1, 2023 | epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sens... | There is potential for discrepant high glucose results in samples with glucose results on the low... | Class II | Siemens Healthcare Diagnostics Inc |
| Jun 1, 2023 | epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc N... | There is potential for discrepant high glucose results in samples with glucose results on the low... | Class II | Siemens Healthcare Diagnostics Inc |
| Jun 1, 2023 | epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Senso... | There is potential for discrepant high glucose results in samples with glucose results on the low... | Class II | Siemens Healthcare Diagnostics Inc |
| May 31, 2023 | UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of ... | Service life of the electrical seat part drive of the treatment chair may be shortened unexpected... | Class II | UFSK - International OSYS Gmbh |
| May 31, 2023 | COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood c... | Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturi... | Class II | Beckman Coulter, Inc. |
| May 31, 2023 | REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, St... | Screws for osteotomies have contain an undersize screwhead which has the potential to pass throug... | Class II | Osteomed, LLC |
| May 31, 2023 | Trexo Device | Electrical issues that could potentially render the device non-functional, give off electromagnet... | Class II | Trexo Robotics Holdings Inc. |
| May 31, 2023 | MICRO-X Rover Mobile X-ray System, # MXU-RV35 | Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough... | Class II | Micro-X Ltd. |
| May 31, 2023 | REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile | Screws for osteotomies have contain an undersize screwhead which has the potential to pass throug... | Class II | Osteomed, LLC |
| May 31, 2023 | Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Ha... | The test medium may not perform as intended. | Class II | Remel, Inc |
| May 30, 2023 | VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs ... | Weld protrusion/physical gap between the housing and pack cover, may exceed design specification,... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| May 30, 2023 | Alinity ci-series System Control Module, REF: 03R70-01 | There are potential performance issues found in the Alinity ci-series System software versions 3.... | Class II | Abbott Laboratories |
| May 30, 2023 | GE Healthcare Vivid S60N, ultrasound device | GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... | Class II | GE Vingmed Ultrasound As |
| May 30, 2023 | Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION W... | The outer package seal could be open, or compromised which affects the sterility of the procedure... | Class II | DeRoyal Industries Inc |
| May 30, 2023 | REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R | Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. | Class II | Limacorporate S.p.A |
| May 30, 2023 | GE Healthcare Vivid S70, ultrasound device | GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... | Class II | GE Vingmed Ultrasound As |
| May 30, 2023 | GE Healthcare Vivid S60, ultrasound device | GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... | Class II | GE Vingmed Ultrasound As |
| May 30, 2023 | REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R | Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. | Class II | Limacorporate S.p.A |
| May 30, 2023 | ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA S... | Medical device components were marketed without FDA clearance and without FDA approval | Class II | Synovo Production |
| May 30, 2023 | ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference N... | Medical device components were marketed without FDA clearance | Class II | Synovo Production |
| May 30, 2023 | Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219 | The outer package seal could be open, or compromised which affects the sterility of the procedure... | Class II | DeRoyal Industries Inc |
| May 30, 2023 | Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF... | The outer package seal could be open, or compromised which affects the sterility of the procedure... | Class II | DeRoyal Industries Inc |
| May 30, 2023 | Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDAR... | The outer package seal could be open, or compromised which affects the sterility of the procedure... | Class II | DeRoyal Industries Inc |
| May 30, 2023 | GE Healthcare Vivid S70N, ultrasound device | GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... | Class II | GE Vingmed Ultrasound As |
| May 30, 2023 | Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY,... | Medical device components were marketed without FDA clearance | Class II | Synovo Production |
| May 30, 2023 | Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK,... | The outer package seal could be open, or compromised which affects the sterility of the procedure... | Class II | DeRoyal Industries Inc |
| May 26, 2023 | Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level dis... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 26, 2023 | Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level di... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 26, 2023 | Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 26, 2023 | VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway managemen... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
| May 26, 2023 | Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 | There was one complaint that the sidearm of the device detached during explant of a pump. When t... | Class II | Abiomed, Inc. |
| May 26, 2023 | Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disi... | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... | Class II | Olympus Corporation of the Americas |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.