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
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	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
Dec 14, 2025	Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, ...	Due to a manufacturing issue and electrical grounding of systems.	Class II	Elekta, Inc.
Dec 12, 2025	Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planni...	Due to an error when defining a new stereotactic reference that users fail to first change an alr...	Class II	Elekta, Inc.
Dec 12, 2025	Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes ...	Six (6) identified software issues which may result in the following: system keeps restarting, AM...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 12, 2025	Philips Azurion system; Software Version Number: R3.1;	Philips has identified two (2) software issues affecting device systems that may result in loss o...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 12, 2025	Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planni...	Due to an error when defining a new stereotactic reference that users fail to first change an alr...	Class II	Elekta, Inc.
Dec 11, 2025	Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Ca...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 11, 2025	Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog ...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 11, 2025	Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges ...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 11, 2025	Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 8155...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 11, 2025	Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog ...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 11, 2025	Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: ...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 11, 2025	Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 10, 2025	Mazor X robotic guidance system REF: TPL0059	Software errors that can result in incorrect surgical instrument positioning during spinal surgery.	Class II	Mazor Robotics Ltd
Dec 9, 2025	Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 ...	increase of complaints regarding the breakage of the ampoules within their device systems. An ext...	Class II	Heraeus Medical GmbH (Dental Division)
Dec 9, 2025	Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/...	increase of complaints regarding the breakage of the ampoules within their device systems. An ext...	Class II	Heraeus Medical GmbH (Dental Division)
Dec 9, 2025	Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Mode...	increase of complaints regarding the breakage of the ampoules within their device systems. An ext...	Class II	Heraeus Medical GmbH (Dental Division)
Dec 9, 2025	Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Mo...	increase of complaints regarding the breakage of the ampoules within their device systems. An ext...	Class II	Heraeus Medical GmbH (Dental Division)
Dec 8, 2025	Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog ...	Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stab...	Class II	IMRIS Imaging Inc
Dec 8, 2025	Philips Azurion Systems R3.0. Includes the following label descriptions and c...	Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal ...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 5, 2025	LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471	A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software ve...	Class II	Siemens Medical Solutions USA, Inc
Dec 4, 2025	Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model...	Due to probe bags that may have a compromised or incomplete sterile pouch seal.	Class II	Intuitive Surgical, Inc.
Dec 3, 2025	A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and...	Complaints received that Vanta A71200 CP App does not function as intended during use. There is a...	Class II	Medtronic Neuromodulation
Dec 3, 2025	BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 1...	Due a software issue that may result in equipment not receiving timely updates of patient, medica...	Class II	CareFusion 303, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, Inc.
Dec 2, 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An...	Affected implants may have undersized distal diameter along length of the shaft, which could lead...	Class II	Zimmer, 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.