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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

3,089 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,089 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 3,089 FDA device recalls.

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DateProductReasonClassFirm
Jan 23, 2026 CS100 IABP. Software Version CS100 IABP Q.01. The firm has identified that the battery runtime and cycle specifications contained in the device... Class II Datascope Corp.
Jan 23, 2026 CS300 IABP. Software Version CS300 IABP C.01. The firm has identified that the battery runtime and cycle specifications contained in the device... Class II Datascope Corp.
Jan 21, 2026 MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-0... Device for bronchoscopic visualization, patient airway access has software issue: if application ... Class II Auris Health, Inc
Jan 20, 2026 cobas pro integrated solutions with cobas c 503 analytical units: cobas pr... Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spl... Class II Roche Diagnostics Operations, Inc.
Jan 16, 2026 Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insuffla... Issue with software algorithm which may lead to overpressure events. Class I Olympus Corporation of the Americas
Jan 16, 2026 Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insuf... Issue with software algorithm which may lead to overpressure events. Class I Olympus Corporation of the Americas
Jan 16, 2026 Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insuff... Issue with software algorithm which may lead to overpressure events. Class I Olympus Corporation of the Americas
Jan 15, 2026 Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM ... There is the potential for the length of the trocar shaft to be too long. Class II Aesculap Inc
Jan 13, 2026 Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3... Pumps were released without full testing being performed, including occlusion alarm testing. Class II Baxter Healthcare Corporation
Jan 9, 2026 Diowave Laser System, REF: Diowave 250W Software update is needed for laser systems, for topical infrared heating to provide temporary re... Class II Technological Medical Advancements LLC
Jan 9, 2026 Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Ca... Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. Class II Medartis AG
Jan 9, 2026 Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Ca... Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. Class II Medartis AG
Jan 7, 2026 Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.; If the connection between a mint Lesion workstation and the mint Lesion server is interrupted whi... Class II Mint Medical GmbH
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Mod... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Dec 31, 2025 Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 ... Products were mislabeled as the 6mm product but included the 5 mm product. Class II Centinel Spine, Inc.
Dec 29, 2025 WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device... Cyber vulnerability of BLE communication was found by CISA VDP program. Class I WHILL, INC.
Dec 29, 2025 WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is... Cyber vulnerability of BLE communication was found by CISA VDP program. Class I WHILL, INC.
Dec 29, 2025 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Materia... Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring si... Class II Siemens Medical Solutions USA, Inc
Dec 29, 2025 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Materia... Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring si... Class II Siemens Medical Solutions USA, Inc
Dec 24, 2025 Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tournique... Device user interface (screen) may freeze or become unresponsive to touch when operating in certa... Class II Zimmer Surgical Inc
Dec 24, 2025 Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tournique... Device user interface (screen) may freeze or become unresponsive to touch when operating in certa... Class II Zimmer Surgical Inc
Dec 23, 2025 CellMek SPS Sample Preparation System, REF: C44603, with software Sample preparation system designed to automate staining, lysing, cell washing has a software erro... Class II Beckman Coulter, Inc.
Dec 23, 2025 Focalyx Fusion Software device that is an accessory for image-guided interventional and diagnostic procedures in... Class II Focalyx Technologies, LLC.
Dec 22, 2025 Patient Information Center iX; Software Version Number: 4.5.0 A recent software (SW) patch modifies Mobile Event Notification filter settings without providing... Class II Philips North America
Dec 19, 2025 NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification ... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Mo... Due to products not having FDA Premarket authorization to be distributed within the United States. Class II MicroPort Orthopedics Inc.
Dec 19, 2025 SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification sy... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Mode... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sampl... Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, a... Class II Sysmex America, Inc.
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer ... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: M... The console label for affected devices is missing the "DANGER" symbol. Class II LEASEIR TECHNOLOGIES SLU
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, 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.