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 |
|---|---|---|---|---|
| Jun 10, 2025 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 5, 2025 | Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog... | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly ... | Class II | Waismed Ltd. |
| Jun 5, 2025 | Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog ... | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly ... | Class II | Waismed Ltd. |
| Jun 2, 2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KN... | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use ... | Class II | Encore Medical, LP |
| Jun 2, 2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KN... | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use ... | Class II | Encore Medical, LP |
| May 30, 2025 | Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Dr... | Kit USB flash drive contains outdated software, which could result in reverting patient monitor t... | Class II | Remote Diagnostic Technologies Ltd. |
| May 29, 2025 | Spectral CT. Computed tomography X-ray system. | Devices with affected software may experience two unintended motion issues that may lead to conta... | Class II | Philips North America Llc |
| May 28, 2025 | Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 72... | A software issue was identified in the internal communication process between the system softwar... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| May 23, 2025 | Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: P... | Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a com... | Class II | Insulet Corporation |
| May 23, 2025 | EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a ... | Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planni... | Class II | QUANTUM SURGICAL SAS |
| May 22, 2025 | Change Healthcare Cardiology Hemo Software | Due to complaints, software update may cause software to unexpectedly shutdown. | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| May 22, 2025 | Change Healthcare Cardiology Hemodynamics Software | Due to complaints, software update may cause software to unexpectedly shutdown. | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| May 21, 2025 | Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen C... | Due to a software/firmware issue diabetes management system may provide a device error and cause ... | Class II | BIGFOOT BIOMEDICAL |
| May 16, 2025 | Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis K... | Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper ... | Class II | THERAKOS DEVELOPMENT LIMITED |
| May 16, 2025 | Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number... | XXX | Class II | Drs Vascular, Inc |
| May 15, 2025 | ARTIS is a family of dedicated angiography systems developed for single and ... | In very rare situations, communication between the sensor measuring dose applied to the area and ... | Class II | Siemens Medical Solutions USA, Inc |
| May 15, 2025 | interventional fluoroscopic x-ray system | In very rare situations, communication between the sensor measuring dose applied to the area and ... | Class II | Siemens Medical Solutions USA, Inc |
| May 15, 2025 | interventional fluoroscopic x-ray system | In very rare situations, communication between the sensor measuring dose applied to the area and ... | Class II | Siemens Medical Solutions USA, Inc |
| May 15, 2025 | interventional fluoroscopic x-ray system | In very rare situations, communication between the sensor measuring dose applied to the area and ... | Class II | Siemens Medical Solutions USA, Inc |
| May 14, 2025 | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannul... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 14, 2025 | Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 14, 2025 | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 14, 2025 | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 14, 2025 | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 14, 2025 | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannul... | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... | Class I | Edwards Lifesciences, LLC |
| May 13, 2025 | Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Ken... | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... | Class II | Cardinal Health 200, LLC |
| May 13, 2025 | Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendal... | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... | Class II | Cardinal Health 200, LLC |
| May 13, 2025 | SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves w... | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... | Class II | Cardinal Health 200, LLC |
| May 9, 2025 | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... | A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2025 | Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog... | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2025 | Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/C... | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 8, 2025 | BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 400... | Antivirus software was not consistently installed on impacted devices during the implementation p... | Class II | CareFusion 303, Inc. |
| May 8, 2025 | Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD P... | During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in... | Class II | CareFusion 303, Inc. |
| May 7, 2025 | Z-800F Infusion System. Intended to provide intravenous infusion of parentera... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Z-800W Infusion System. Intended to provide intravenous infusion of parentera... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Z-800WF Infusion System. Intended to provide intravenous infusion of parenter... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Z-800 Infusion System. Intended to provide intravenous infusion of parenteral... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM0000... | Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ... | Class II | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| May 6, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium ... | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or u... | Class II | Olympus Corporation of the Americas |
| May 6, 2025 | PhenoMATRIX | AI-powered bacterial culture plate interpretation and workup software does not have Premarket App... | Class II | Copan WASP |
| May 2, 2025 | LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software... | Firm has identified Drug Library Management defects in the software: 1) DLM software does not all... | Class II | ICU Medical, Inc. |
| Apr 28, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... | Due to the potential that some units within specific lots were damaged during the manufacturing p... | Class II | Alcon Research LLC |
| Apr 28, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision Syst... | Due to the potential that some units within specific lots were damaged during the manufacturing p... | Class II | Alcon Research LLC |
| Apr 28, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision Syst... | Due to the potential that some units within specific lots were damaged during the manufacturing p... | Class II | Alcon Research LLC |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Cat... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Cat... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
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.