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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

3,007 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,007 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 3,007 FDA device recalls.

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DateProductReasonClassFirm
Jan 30, 2026 Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a dev... There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... Class II GE Medical Systems, LLC
Jan 30, 2026 HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: ... Due to complaints and investigations stating that alarms from the primary patient bedside monitor... Class II Covidien LLC
Jan 30, 2026 DxC 700 AU, REF: B86444, B86446 A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal... Class II Beckman Coulter Mishima K.K.
Jan 30, 2026 CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal... Class II Beckman Coulter Mishima K.K.
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TR... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SP... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOS... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 200... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRA... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 29, 2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model... B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... Class II B Braun Medical Inc
Jan 26, 2026 Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Softwa... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Sof... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)7... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version ... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Soft... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)7222... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026 Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Softwa... Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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.

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.