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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,831 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,831 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 2,831 FDA device recalls in 2025.

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DateProductReasonClassFirm
May 13, 2025 Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152; Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) ... Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 78127... Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148; Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Allon 2001. Part Number: 200-00263 An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exce... Class II Belmont Instrument 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 Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3)... Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America 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 Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2)... Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Lago X The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not c... Class II Spectral Instruments Inc
May 13, 2025 Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) ... Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3)... Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: SmartPath to dStream for 3.0T; Model Number: 782145 Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: Ingenia 1.5T S; Model Number: 781347; Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103; Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) ... Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America 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 13, 2025 Ami HTX. The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not c... Class II Spectral Instruments Inc
May 13, 2025 Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153; Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: Ingenia 1.5T CX; Model Number: 781262; Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: Ingenia 3.0T CX; Model Number: 781271; Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143; Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 12, 2025 BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010... Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... Class II BD SWITZERLAND SARL
May 12, 2025 Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-... Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... Class I Dexcom, Inc.
May 12, 2025 Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & ST... Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... Class I Dexcom, Inc.
May 12, 2025 Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With... Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... Class II BD SWITZERLAND SARL
May 12, 2025 Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-00... Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... Class I Dexcom, Inc.
May 12, 2025 Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-01... Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... Class I Dexcom, Inc.
May 12, 2025 BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China)... Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... Class II BD SWITZERLAND SARL
May 12, 2025 Baxter Novum IQ Syringe Pump, product code 40800BAXUS, Baxter has identified a design issue which may cause the pump to detect the presence of a syringe... Class II Baxter Healthcare Corporation
May 12, 2025 BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, R... Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... Class II BD SWITZERLAND SARL
May 12, 2025 The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue G... Glucose microcuvettes experienced transit time outside of limits, so stability through the whole ... Class II HemoCue AB
May 12, 2025 BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500 Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... Class II BD SWITZERLAND SARL
May 12, 2025 IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low... Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filte... Class I Fresenius Kabi USA, LLC
May 9, 2025 Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K... Cathode ray tube display system encoders and decoders have same MAC address; new system setup wit... Class II Barco N.V.
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 BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in... This device does not indicate for use in patients with respiratory failure. Class I Philips Respironics, Inc.
May 9, 2025 BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the... This device does not indicate for use in patients with respiratory failure. Class I Philips Respironics, Inc.
May 9, 2025 BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory suppo... This device does not indicate for use in patients with respiratory failure. Class I Philips Respironics, 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 9, 2025 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope ... The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the... Class II Baxter Healthcare Corporation
May 8, 2025 Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BL... Due to radiopaque (RO) marker was not visible during angiography and it was determined that the R... Class II BALT USA, LLC
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 Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1... Due to radiopaque (RO) marker was not visible during angiography and it was determined that the R... Class II BALT USA, LLC
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 8, 2025 GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will g... Class II Ohio Medical Corporation
May 7, 2025 DxI 9000 Access Immunoassay Analyzer C11137 Analyzer has calibration issues where curves switched from passed to failed due to system errors ... Class II Beckman Coulter, 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

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.