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
Aug 8, 2025	RayStation with the following product descriptions: 1. RayStation 11B, So...	DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i...	Class II	RAYSEARCH LABORATORIES AB
Aug 5, 2025	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni...	Due to incomplete seals in the pouch which provide the sterile barrier.	Class II	Alcon Research LLC
Aug 5, 2025	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni...	Due to incomplete seals in the pouch which provide the sterile barrier.	Class II	Alcon Research LLC
Aug 5, 2025	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni...	Due to incomplete seals in the pouch which provide the sterile barrier.	Class II	Alcon Research LLC
Aug 5, 2025	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni...	Due to incomplete seals in the pouch which provide the sterile barrier.	Class II	Alcon Research LLC
Aug 5, 2025	Pinnacle Radiation Therapy Planning System: Multimodality Simulation Works...	Due to a software issue, there is a potential image error of the Region of Interest for expansion...	Class II	Philips Medical Systems (Cleveland) Inc
Aug 5, 2025	t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology,...	A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and ve...	Class II	Tandem Diabetes Care, Inc.
Aug 5, 2025	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni...	Due to incomplete seals in the pouch which provide the sterile barrier.	Class II	Alcon Research LLC
Aug 4, 2025	Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump	Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar...	Class I	Baxter Healthcare Corporation
Aug 4, 2025	Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump	Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar...	Class I	Baxter Healthcare Corporation
Aug 4, 2025	Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump	Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar...	Class I	Baxter Healthcare Corporation
Jul 31, 2025	Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Nam...	The potential of the elastic bands included in the kit detaching or fracturing during surgical pr...	Class II	Lumicell, Inc.
Jul 25, 2025	ZAP-X Radiosurgery System, Model: 300150	If the radiosurgery system triggers a proximity error message during a long gantry move (greater-...	Class II	Zap Surgical Systems
Jul 24, 2025	Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 24, 2025	Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 24, 2025	Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Softwa...	The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o...	Class II	THOR Photomedicine Ltd
Jul 24, 2025	Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Numbe...	The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o...	Class II	THOR Photomedicine Ltd
Jul 24, 2025	Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Sof...	The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o...	Class II	THOR Photomedicine Ltd
Jul 24, 2025	Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 24, 2025	Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Cat...	The defect in the thread area will not allow the device to fully engage with an implant or analog...	Class II	Dentsply IH, Inc.
Jul 24, 2025	Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 24, 2025	Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Numbe...	The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o...	Class II	THOR Photomedicine Ltd
Jul 24, 2025	Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 22, 2025	RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X1100...	Due to incorrect software configuration that potentially allows more than two (2) fractions withi...	Class II	Reflexion Medical, Inc.
Jul 21, 2025	Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Mode...	The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.	Class II	B.Braun Medical S.A.S.
Jul 21, 2025	STA Satellite. Product Code: All references. All software versions. The ST...	Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap...	Class II	Diagnostica Stago, Inc.
Jul 19, 2025	Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit M...	Device contains indications for use and device compatibility claims that have not be reviewed and...	Class II	Insightra Medical Inc
Jul 18, 2025	Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray M...	Their is a potential that the reamer may kick or bind up during or immediately prior to use.	Class II	Encore Medical, LP
Jul 17, 2025	Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software	Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculati...	Class II	Philips Medical Systems (Cleveland) Inc
Jul 17, 2025	Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant ...	Measles IgM Test Kit lacks premarket approval or clearance.	Class II	Quest International, Inc.
Jul 14, 2025	3mensio Workstation (Vascular Fenestrated) software	When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (i...	Class II	PIE Medical Imaging B.V.
Jul 14, 2025	Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001...	Under certain conditions, such as the simultaneous use of the operating table with other medical ...	Class II	MAQUET GMBH
Jul 10, 2025	Multi Joystick R-net. Electrical wheelchair component.	Devices with firmware versions 2.3 and lower may experience timing variations between software ta...	Class I	mo-Vis BVBA
Jul 10, 2025	IDM-MULTI-R. Electrical wheelchair component.	Devices with firmware versions 2.3 and lower may experience timing variations between software ta...	Class I	mo-Vis BVBA
Jul 10, 2025	All-round Joystick R-net Light. Electrical wheelchair component.	Devices with firmware versions 2.3 and lower may experience timing variations between software ta...	Class I	mo-Vis BVBA
Jul 10, 2025	IDM-ARLITE-R. Electrical wheelchair component.	Devices with firmware versions 2.3 and lower may experience timing variations between software ta...	Class I	mo-Vis BVBA
Jul 10, 2025	Micro Joystick R-net. Electrical wheelchair component.	Devices with firmware versions 2.3 and lower may experience timing variations between software ta...	Class I	mo-Vis BVBA
Jul 10, 2025	IDM-MICRO-R. Electrical wheelchair component.	Devices with firmware versions 2.3 and lower may experience timing variations between software ta...	Class I	mo-Vis BVBA
Jul 8, 2025	BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions	Infusion pump module used with compatible pump infusion sets may perform outside the establishe...	Class I	CareFusion 303, Inc.
Jun 30, 2025	Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD...	Potential for temporary loss of imaging (X-ray) functionality due to software issue.	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 30, 2025	Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SC...	Cannulated fenestrated polyaxial screws may be incorrectly labeled	Class II	SPINEART SA
Jun 30, 2025	Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SC...	Cannulated fenestrated polyaxial screws may be incorrectly labeled	Class II	SPINEART SA
Jun 26, 2025	VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation ...	Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas ...	Class II	bioMerieux, Inc.
Jun 25, 2025	UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100	Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries...	Class II	Beckman Coulter, Inc.
Jun 25, 2025	UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260	Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries...	Class II	Beckman Coulter, Inc.
Jun 25, 2025	DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461	Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries...	Class II	Beckman Coulter, Inc.
Jun 25, 2025	DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456	Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries...	Class II	Beckman Coulter, Inc.
Jun 25, 2025	DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460	Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries...	Class II	Beckman Coulter, Inc.
Jun 25, 2025	DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457	Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries...	Class II	Beckman Coulter, Inc.
Jun 23, 2025	Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:...	Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking...	Class I	Thoratec LLC

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.