Browse Device Recalls

2,945 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,945 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 2,945 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jun 23, 2025	BD COR System Software. Model Number: 444829.	Potential for functionality issue that supports the Over labeling feature and could lead to poss...	Class II	Becton Dickinson & Co.
Jun 23, 2025	Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/...	Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking...	Class I	Thoratec LLC
Jun 20, 2025	Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine ...	Unintended radial detector motion may occur during patient setup or during patient scan if system...	Class II	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Jun 20, 2025	Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine s...	Unintended radial detector motion may occur during patient setup or during patient scan if system...	Class II	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Jun 20, 2025	Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2	Certain Spectrum infusion pumps may have an incorrect version of software.	Class I	Baxter Healthcare Corporation
Jun 20, 2025	Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX	Certain Spectrum infusion pumps may have an incorrect version of software.	Class I	Baxter Healthcare Corporation
Jun 18, 2025	Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/C...	There is the potential that the silicone implant may contain foreign material	Class II	Osteotec Limited
Jun 18, 2025	Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the fol...	In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur...	Class II	Medtronic, Inc.
Jun 18, 2025	Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the f...	In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur...	Class II	Medtronic, Inc.
Jun 17, 2025	Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Mod...	A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ...	Class II	Medtronic, Inc.
Jun 17, 2025	Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Num...	A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ...	Class II	Medtronic, Inc.
Jun 16, 2025	InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)	Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design e...	Class II	Medtronic MiniMed, Inc.
Jun 12, 2025	Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi...	Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued di...	Class II	Encore Medical, LP
Jun 12, 2025	Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi...	Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued di...	Class II	Encore Medical, LP
Jun 11, 2025	ASPRIRE Cristalle Mammography System (cleared under K212873) installed with t...	Devices had an unapproved slabbing software function enabled for use.	Class II	FUJIFILM Healthcare Americas Corporation
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 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: 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.

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.