Browse Device Recalls
3,007 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,007 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 3,007 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 6, 2026 | LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. | Potential software anomaly that can cause the pump to report a false battery-health value (typica... | Class I | Fresenius Kabi USA, LLC |
| Apr 30, 2026 | Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI ... | Due to incorrect shelf-life expiration date. | Class II | Advanced Bionics, LLC |
| Apr 24, 2026 | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Nu... | Due to unintentionally activated near infrared handheld camera when attempting to turn off illumi... | Class II | Intuitive Surgical, Inc. |
| Apr 24, 2026 | GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - O... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 21, 2026 | MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analys... | Software in development inadvertently made available for customer use. Use of this software versi... | Class II | GE Medical Systems China Co., Ltd. |
| Apr 14, 2026 | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... | A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... | Class II | Dexcom, Inc. |
| Apr 14, 2026 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... | Class II | Dexcom, Inc. |
| Apr 14, 2026 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... | Class II | Dexcom, Inc. |
| Apr 8, 2026 | Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software ... | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode,... | Class II | Medtronic Neuromodulation |
| Apr 2, 2026 | Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgica... | Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to break... | Class II | Intuitive Surgical, Inc. |
| Mar 30, 2026 | Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl a... | Ten complaints have been received identifying issues at the time of use related to the package se... | Class II | Zimmer, Inc. |
| Mar 27, 2026 | AIDBAGs are first aid kits of convenience composed of individually labeled de... | Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has b... | Class I | North American Rescue LLC. |
| Mar 26, 2026 | Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command M... | Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). | Class II | Spacelabs Healthcare, Inc. |
| Mar 24, 2026 | Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR u... | Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys ... | Class II | Foundation Medicine, Inc. |
| Mar 23, 2026 | Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery P... | The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-... | Class II | Advanced Bionics, LLC |
| Mar 23, 2026 | Brand Name: Genius" Review Station Product Name: Genius" Review Station Disp... | It was identified that certain devices were being operated outside the validated and FDA-cleared ... | Class II | Hologic, Inc |
| Mar 23, 2026 | Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; | The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (... | Class II | Gentuity, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Nu... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Nu... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: ... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Nu... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Car... | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... | Class I | Boston Scientific Corporation |
| Mar 19, 2026 | Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VA... | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... | Class I | Boston Scientific Corporation |
| Mar 19, 2026 | Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software me... | Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (I... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 12, 2026 | iLet Bionic Pancreas, REF: BB1001 | insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring ... | Class II | Beta Bionics, Inc. |
| Mar 7, 2026 | Philips Spectral CT on Rails. Model Number: 728334. | Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the... | Class II | PHILIPS MEDICAL SYSTEMS |
| Mar 6, 2026 | CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical ... | Software issue that renders the touch screen unresponsive. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Mar 4, 2026 | Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2... | Product labeling includes a fetal indication for use that is not cleared under its 510(k). | Class II | Koven Technology, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Feb 20, 2026 | Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL... | Due to a quality issue regarding the presence of burr on the finished cervical plate product. | Class II | Clariance-SAS |
| Feb 19, 2026 | Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Produ... | Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to... | Class II | AMO Puerto Rico Manufacturing, Inc. |
| Feb 18, 2026 | Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener... | Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights... | Class II | Baxter Healthcare Corporation |
| Feb 9, 2026 | RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 | Due to a radiotherapy medical system software defect, when performing angular roll corrections fo... | Class II | Reflexion Medical, Inc. |
| Feb 9, 2026 | Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Softw... | It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to ... | Class II | Abbott Diagnostics Scarborough, Inc. |
| Feb 6, 2026 | Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR | Software anomaly in the patient positioning system may result in positional discrepancy. | Class II | Hitachi, Ltd. Radiation Oncology Systems, Kashi... |
| Feb 6, 2026 | Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR | Software anomaly in the patient positioning system may result in positional discrepancy. | Class II | Hitachi, Ltd. Radiation Oncology Systems, Kashi... |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Mod... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Ca... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Jan 30, 2026 | Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a devi... | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... | Class II | GE Medical Systems, LLC |
| Jan 30, 2026 | Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a... | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... | Class II | GE Medical Systems, LLC |
| Jan 30, 2026 | MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and ... | Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that ... | Class II | Medtronic MiniMed, Inc. |
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.