Browse Device Recalls

2,805 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,805 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 2,805 FDA device recalls in 2025.

Date	Product	Reason	Class	Firm
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	Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ing...	Due to damage to outer tray that can potentially compromise the sterile barrier	Class II	Bard Peripheral Vascular Inc
Dec 12, 2025	Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, K...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
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	Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PA...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN...	Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Mi...	Class II	Integra LifeSciences Corp. (NeuroSciences)
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	The product is used for the evaluation of the intrinsic coagulation pathway, ...	Potential for microbial contamination.	Class II	Instrumentation Laboratory
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	Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23	There is the potential for extended length of the blade obturator after assembly into the cannula...	Class II	Applied Medical Resources Corp
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	MAXXUS, System, Tomography, Computed, Emission	GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua...	Class II	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
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 10, 2025	SMV DSX New Line, System, Tomography, Computed, Emission	GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua...	Class II	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 10, 2025	SMV BodyTrack, System, Tomography, Computed, Emission	GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua...	Class II	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 10, 2025	SMV DSI, System, Tomography, Computed, Emission	GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua...	Class II	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 10, 2025	MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a ...	Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical b...	Class II	REPLIGEN CORPORATION
Dec 10, 2025	MOSAIQ Oncology Information System with Particle Therapy License (License Ki...	Using oncology information system that manages workflow may result in overtreatment if:Plan deliv...	Class II	Elekta, Inc.
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	Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1...	Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lo...	Class II	Securitas Healthcare LLC
Dec 8, 2025	Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version:...	Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lo...	Class II	Securitas Healthcare LLC
Dec 8, 2025	The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a...	Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim list...	Class II	Beckman Coulter Ireland, Inc.
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	Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Numbe...	Incorrect expiration date	Class II	LimFlow, Inc.
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 5, 2025	Revogene C. difficile, in vitro diagnostic assay intended for use with the Re...	The affected lots show a decline in performance over time, which may lead to false-negative results.	Class II	Meridian Bioscience Inc
Dec 5, 2025	BVI Leos Laser and Endoscopy System. Model Number: OME6000U.	Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nu...	Class II	Beaver-Visitec International, 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 4, 2025	Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.	Device packaged in incorrect outer box carton.	Class II	Abiomed, Inc.
Dec 4, 2025	Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G1210...	Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed a...	Class II	Medtronic Inc
Dec 4, 2025	Allwell Angioplasty Pack REF: IS-30-B1/B	Inflation device handle may detach from the syringe during procedure.	Class II	Merit Medical Systems, Inc.
Dec 4, 2025	Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07...	Inflation device handle may detach from the syringe during procedure.	Class II	Merit Medical Systems, Inc.
Dec 4, 2025	Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (C...	AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.	Class II	Mobius Imaging, LLC
Dec 4, 2025	Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K...	Inflation device handle may detach from the syringe during procedure.	Class II	Merit Medical Systems, Inc.
Dec 4, 2025	Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261	Inflation device handle may detach from the syringe during procedure.	Class II	Merit Medical Systems, Inc.
Dec 4, 2025	Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (C...	AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.	Class II	Mobius Imaging, LLC
Dec 4, 2025	Merit Medical , Custom Manifold Kit REF: K09-13203A	Inflation device handle may detach from the syringe during procedure.	Class II	Merit Medical Systems, Inc.
Dec 4, 2025	Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Number...	Inflation device handle may detach from the syringe during procedure.	Class II	Merit Medical Systems, Inc.
Dec 4, 2025	Allwell Inflation Device, for angiographic use REF: IS-30-A	Inflation device handle may detach from the syringe during procedure.	Class II	Merit Medical Systems, Inc.
Dec 3, 2025	Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with...	The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma...	Class II	Philips North America
Dec 3, 2025	Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1...	Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Per...	Class II	Boston Scientific Corporation
Dec 3, 2025	Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW versio...	The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma...	Class II	Philips North America

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.