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.

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DateProductReasonClassFirm
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: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 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, 44" 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:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 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 34" 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, 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:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 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 12" 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, 15" 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: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" 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 BB TOURNQUET CUFF, 26" X 6" ... 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 18" 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, 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: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26" DUAL BLADDER, 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, 44" 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, 18" 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, 38" 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, 18" 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: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" 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 BB TOURNQUET CUFF, 20" X 6" ... 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: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" 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, 12" X 3.5" 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, 18" 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, 30" 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, 20" 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: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 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 BB TOURNQUET CUFF, 26" X 6" ... 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, 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 21, 2026 Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.);... Software issues may affect the safety and performance of Spectral CT system(s). The issues may re... Class II PHILIPS MEDICAL SYSTEMS
Aug 21, 2026 SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dS... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Int... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 7... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 7... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253; A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 78... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 MR 5300 Model Number (REF): 1. 782110, 2. 782152; A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3.... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), ... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 21, 2026 Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 78134... A software issue will terminate an examination during the image reconstruction process if the sca... Class II Philips North America Llc
Aug 20, 2026 EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number... Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration... Class II Bard Peripheral Vascular Inc
Aug 20, 2026 Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC... Due to issue with endoscope adherence and inability to spray powder. Firm will provide an update... Class II Wilson-Cook Medical Inc.
Aug 18, 2026 Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x,... The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots ma... Class II Philips North America Llc
Aug 12, 2026 Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia ... Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could ... Class II BioFire Diagnostics, LLC
Aug 12, 2026 Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumo... Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could ... Class II BioFire Diagnostics, LLC
Aug 12, 2026 Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Join... Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could ... Class II BioFire Diagnostics, LLC
Aug 11, 2026 Positron Emission Tomography and Computed Tomography System, Model: uMI 780 Positron emission tomography and computed tomography x-ray systems have a software problem when S... Class II Shanghai United Imaging Healthcare Co., Ltd.

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.