Browse Device Recalls
3,089 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,089 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 3,089 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 25, 2025 | Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Ver... | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... | Class II | PHILIPS MEDICAL SYSTEMS |
| Sep 24, 2025 | Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/C... | It was determined there is the potential of silicone fragments detaching from the yellow sealing ... | Class II | Aesculap Inc |
| Sep 24, 2025 | Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Ca... | It was determined there is the potential of silicone fragments detaching from the yellow sealing ... | Class II | Aesculap Inc |
| Sep 24, 2025 | Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/... | It was determined there is the potential of silicone fragments detaching from the yellow sealing ... | Class II | Aesculap Inc |
| Sep 24, 2025 | Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER ... | It was determined there is the potential of silicone fragments detaching from the yellow sealing ... | Class II | Aesculap Inc |
| Sep 23, 2025 | BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), C... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 22, 2025 | DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 T... | Due to a software error code that crashes during acquisition on patient sample when running custo... | Class II | Beckman Coulter Inc. |
| Sep 19, 2025 | DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part N... | Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the ... | Class II | Beckman Coulter, Inc. |
| Sep 19, 2025 | DxI 9000 Access Immunoassay Analyzer, Part Number C11137 | Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the ... | Class II | Beckman Coulter, Inc. |
| Sep 19, 2025 | Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27... | Complaint identified issue with AI surgical planning software that may result in implant malalig... | Class II | Kico Knee Innovation Company |
| Sep 18, 2025 | LOGIQ P10 series with software version R4.5.7 Model Number 5877534 | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values... | Class II | GE Medical Systems, LLC |
| Sep 18, 2025 | LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model N... | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values... | Class II | GE Medical Systems, LLC |
| Sep 18, 2025 | Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Cat... | Software issue for hq analyzer results in system not visibly applying appropriate flagging to res... | Class II | Abbott Laboratories |
| Sep 18, 2025 | LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Mod... | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values... | Class II | GE Medical Systems, LLC |
| Sep 17, 2025 | MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.... | When appending a care plan that contains one or more wave medication orders, the occurrence and ... | Class II | ELEKTA SOLUTIONS AB |
| Sep 16, 2025 | SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP)... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 9... | Due to two distinct issues: 1. During patient admission, patient demographic fields may default ... | Class II | Spacelabs Healthcare, Ltd. |
| Sep 16, 2025 | Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software ... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, im... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), sof... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmente... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radio... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 9, 2025 | Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 ... | The device either indicated a failure of the piston ventilator before use or suffered a failure o... | Class I | Draeger, Inc. |
| Sep 9, 2025 | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 S... | The device either indicated a failure of the piston ventilator before use or suffered a failure o... | Class I | Draeger, Inc. |
| Sep 9, 2025 | Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build ... | Potential that the measured value may be smaller than the actual area. | Class II | MedicalCommunications GmbH |
| Sep 8, 2025 | CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122... | Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis d... | Class II | Beckman Coulter, Inc. |
| Sep 5, 2025 | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm ... | Due to products that have not completed design updates and performance testing being released/dis... | Class II | Exactech, Inc. |
| Sep 5, 2025 | Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter M... | Due to products that have not completed design updates and performance testing being released/dis... | Class II | Exactech, Inc. |
| Sep 5, 2025 | Brand Name: Branding is not applied to this product. Product Name: DVI displ... | Due to display cables used for monitors were not in compliance with electromagnetic interference ... | Class II | Spacelabs Healthcare, Inc. |
| Sep 5, 2025 | Brand Name: Branding is not applied to this product. Product Name: DVI displ... | Due to display cables used for monitors were not in compliance with electromagnetic interference ... | Class II | Spacelabs Healthcare, Inc. |
| Sep 5, 2025 | GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with softwar... | GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software v... | Class II | Wipro GE Healthcare Private Ltd. |
| Sep 5, 2025 | Brand Name: Branding is not applied to this product. Product Name: DVI displ... | Due to display cables used for monitors were not in compliance with electromagnetic interference ... | Class II | Spacelabs Healthcare, Inc. |
| Sep 5, 2025 | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm ... | Due to products that have not completed design updates and performance testing being released/dis... | Class II | Exactech, Inc. |
| Sep 5, 2025 | GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with softwar... | GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software v... | Class II | Wipro GE Healthcare Private Ltd. |
| Sep 2, 2025 | This device is a digital radiography/fluoroscopy system used in a diagnostic ... | It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the c... | Class II | Canon Medical System, USA, INC. |
| Aug 28, 2025 | Sharesource Connectivity Platform for Use with Homechoice Claria Product C... | Vantive has identified a software defect within the Sharesource Claria software, which may cause ... | Class II | Vantive US Healthcare LLC |
| Aug 28, 2025 | Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dex... | A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpec... | Class I | Dexcom, Inc. |
| Aug 22, 2025 | Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 ... | Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dro... | Class II | Sonesta Medical AB |
| Aug 21, 2025 | Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to iden... | Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification featu... | Class II | Bard Peripheral Vascular Inc |
| Aug 20, 2025 | ACCOLADE DR SL MRI (Model L311) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number S722, ALTRUA 2 DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | PROPONENT DR SL (Model L201) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE SR SL MRI (Model L310) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L100, ESSENTIO SR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U125, VALITUDE CRT-P EL | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE SR SL (Model L300) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L111, ESSENTIO DR SL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number S701 ALTRUA 2 SR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE DR EL (Model L321) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
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.