Browse Device Recalls

2,945 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,945 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 2,945 FDA device recalls.

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Date	Product	Reason	Class	Firm
Mar 4, 2026	Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2...	Product labeling includes a fetal indication for use that is not cleared under its 510(k).	Class II	Koven Technology, Inc.
Mar 2, 2026	Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home...	Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ...	Class I	Philips Respironics, Inc.
Mar 2, 2026	Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h...	Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ...	Class I	Philips Respironics, Inc.
Mar 2, 2026	Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho...	Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ...	Class I	Philips Respironics, Inc.
Mar 2, 2026	Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti...	Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ...	Class I	Philips Respironics, Inc.
Feb 19, 2026	Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Produ...	Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to...	Class II	AMO Puerto Rico Manufacturing, Inc.
Feb 18, 2026	Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener...	Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights...	Class II	Baxter Healthcare Corporation
Feb 9, 2026	Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Softw...	It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to ...	Class II	Abbott Diagnostics Scarborough, Inc.
Feb 6, 2026	Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR	Software anomaly in the patient positioning system may result in positional discrepancy.	Class II	Hitachi, Ltd. Radiation Oncology Systems, Kashi...
Feb 6, 2026	Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR	Software anomaly in the patient positioning system may result in positional discrepancy.	Class II	Hitachi, Ltd. Radiation Oncology Systems, Kashi...
Feb 2, 2026	Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Mod...	The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.	Class II	B Braun Medical Inc
Feb 2, 2026	Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Ca...	The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.	Class II	B Braun Medical Inc
Feb 2, 2026	Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number...	The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.	Class II	B Braun Medical Inc
Jan 30, 2026	Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a devi...	There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers...	Class II	GE Medical Systems, LLC
Jan 30, 2026	Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a...	There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers...	Class II	GE Medical Systems, LLC
Jan 30, 2026	MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and ...	Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that ...	Class II	Medtronic MiniMed, Inc.
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 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	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	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

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.