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 |
|---|---|---|---|---|
| Jul 22, 2026 | FUJIFILM Synapse PACS software v7.4.310; radiological image processing system | Software issue may cause the ruler measurement to be inaccurate. | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 22, 2026 | Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation | Software issue may cause measurements to be displayed inaccurately. | Class II | Merge Healthcare, Inc. |
| Jul 20, 2026 | PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Soft... | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an i... | Class II | Midmark Corporation |
| Jul 20, 2026 | FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 570... | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software ... | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an i... | Class II | Midmark Corporation |
| Jul 20, 2026 | PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 16, 2026 | Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 7220... | Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degr... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jul 16, 2026 | Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 7222... | Two software related issues: 1) Potential image quality degradation that may lead to delay of t... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jul 15, 2026 | Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5... | a software defect in which the Parameter Package (PP) import logic overwrites all predefined cal... | Class II | Beckman Coulter Inc. |
| Jul 15, 2026 | Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1... | a software defect in which the Parameter Package (PP) import logic overwrites all predefined cal... | Class II | Beckman Coulter Inc. |
| Jul 13, 2026 | Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYS... | Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the ... | Class II | Kico Knee Innovation Company |
| Jul 10, 2026 | GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitor... | A software vulnerability may allow unauthorized persons to gain privileged access to the device, ... | Class II | GE Medical Systems Information Technologies Inc |
| Jun 30, 2026 | Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas St... | Due to incorrect machining of peripheral screw hole resulting in potential for improper engagemen... | Class II | restor3d Inc. |
| Jun 30, 2026 | SnapshotGLO Wound Imaging Device, Model KB100, KB100AA. | The software controlling the wound imaging device's battery charging circuit was not designed to ... | Class II | KENT IMAGING, INC. |
| Jun 29, 2026 | GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph | Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an ... | Class II | GE Medical Systems Information Technologies Inc |
| Jun 26, 2026 | Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product ... | Potential of failing to trigger clinical scan during Bolus Tracking. | Class II | Philips Healthcare (Suzhou) Co., Ltd. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Nu... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number:... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Numb... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Numbe... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Num... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 19, 2026 | munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control ... | A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When th... | Class II | MUNEVO GMBH |
| Jun 19, 2026 | Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M001... | Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns t... | Class II | Boston Scientific Corporation |
| Jun 16, 2026 | Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Softw... | Due to a software issue within the WebApp that potentially prevents the user to overwrite the res... | Class II | Copan WASP |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 15, 2026 | Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 11, 2026 | Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model... | Due to a defective circuit board that overheats | Class II | Oxos Medical Inc |
| Jun 10, 2026 | Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0... | Software issue that can cause an increase in spontaneous software closures. | Class II | Foundation Medicine, Inc. |
| Jun 9, 2026 | Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console ... | Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersec... | Class II | CMR SURGICAL LIMITED |
| Jun 9, 2026 | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... | Class II | Zimmer Surgical Inc |
| Jun 9, 2026 | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... | Class II | Zimmer Surgical Inc |
| Jun 5, 2026 | Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model... | May contain incorrect connectors and will not attach or misconnect to ENFit connections and is th... | Class II | Medela Inc |
| Jun 4, 2026 | Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Numbe... | Due to off-the-shelf display port component that has audio/video failures | Class II | Spacelabs Healthcare, Inc. |
| May 29, 2026 | Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano... | Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorde... | Class II | Emano Metrics, 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.