Browse Device Recalls
3,235 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,235 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 3,235 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 23, 2026 | HexaVue Focus Integration System, a single, all-in-one system that handles op... | A software issue may result in unintended mismatch of patient information on manually printed ima... | Class II | Steris Corporation |
| Sep 8, 2026 | Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Cata... | Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploite... | Class II | Nihon Kohden America LLC |
| Sep 2, 2026 | DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 ... | Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when test... | Class II | Beckman Coulter Inc. |
| Sep 2, 2026 | DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, ... | Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testin... | Class II | Beckman Coulter Inc. |
| Aug 28, 2026 | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dS... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R1... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S),... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... | Class II | Philips North America |
| Aug 28, 2026 | SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software V... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; So... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 a... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 78... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. ... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... | Class II | Philips North America |
| Aug 28, 2026 | MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; So... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... | Class II | Philips North America |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 1 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5"... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 2 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5"... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 8" 2 LINE (10) Mode... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 1 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 2 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 26" X 6" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 2 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" ... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" ... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5"... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
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.