Browse Device Recalls

38,509 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 38,509 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 38,509 FDA device recalls.

Date	Product	Reason	Class	Firm
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
Dec 3, 2025	Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. ...	The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma...	Class II	Philips North America
Dec 3, 2025	Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. ...	The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma...	Class II	Philips North America
Dec 3, 2025	SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR syst...	The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma...	Class II	Philips North America
Dec 3, 2025	Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW ve...	The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma...	Class II	Philips North America
Dec 3, 2025	Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. ...	The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma...	Class II	Philips North America
Dec 3, 2025	Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R...	The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma...	Class II	Philips North America
Dec 3, 2025	MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW v...	The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma...	Class II	Philips North America
Dec 3, 2025	Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. 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	Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR s...	The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma...	Class II	Philips North America
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 3, 2025	Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW versio...	The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma...	Class II	Philips North America
Dec 3, 2025	Philips Incisive CT	Potential for incomplete scan due to unstable connection inside of floating sensor.	Class II	Philips Healthcare (Suzhou) Co., Ltd.
Dec 3, 2025	SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems wit...	The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma...	Class II	Philips North America
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.
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.
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	LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalo...	Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de...	Class II	Microbiologics Inc
Dec 2, 2025	KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,...	Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de...	Class II	Microbiologics 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.