Browse Device Recalls
40,358 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 40,358 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 40,358 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 31, 2026 | Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panora... | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/... | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | VERIFY Biological Steam Test Pack Model/Catalog Number: S3069 | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/... | Certain monitor operator's manuals contain descriptions that may be insufficient or may require c... | Class III | Mindray DS USA, Inc. |
| Aug 31, 2026 | VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007 | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Numb... | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number... | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Biological Steam Test Pack Model/Catalog Number: S3065 | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 28, 2026 | TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88; | Devices failed in process testing related to the amount of pull force it can sustain prior to the... | Class II | LeMaitre Vascular, Inc. |
| Aug 28, 2026 | Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Int... | A navigation system used to aid in selection and positioning of orthopedic implant system compone... | Class II | Intellijoint Surgical, 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 27, 2026 | Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delive... | The implantable clip may experience difficulties deploying, which could prevent the reflector fro... | Class II | Merit Medical Systems, Inc. |
| Aug 27, 2026 | Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an... | While in the high-power operating mode, a video dropout/blackout may occur when using a particula... | Class II | Olympus Corporation of the Americas |
| Aug 26, 2026 | Alphenix INFX-8000C/B5 | Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shi... | Class II | Canon Medical System, USA, INC. |
| Aug 26, 2026 | HALYARD Laparoscopy Comprehensive Pack II REF: 49332 | Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter | Class II | GRI Medical & Electronic Technology Co., Ltd. |
| Aug 25, 2026 | SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000; | During use of an affected tube, the operator may encounter increased resistance when inserting th... | Class II | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC P... |
| Aug 24, 2026 | NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Pa... | Cables are not in conformance with the product specifications required in the production of the H... | Class II | Neuronetics, Inc. |
| Aug 24, 2026 | Glypto Device, Glypto Cryo Machine; | Lack of 510(k) clearance. | Class II | Limitless Cryo Spa LLC |
| 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. |
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.