Browse Device Recalls

2,817 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,817 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 2,817 FDA device recalls in 2025.

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Date	Product	Reason	Class	Firm
Nov 11, 2025	Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. ...	Complaints of the ceramic tip of the resection sheath breaking have been received.	Class II	Olympus Corporation of the Americas
Nov 11, 2025	Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment...	Complaints of the ceramic tip of the resection sheath breaking have been received.	Class II	Olympus Corporation of the Americas
Nov 11, 2025	Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T...	Complaints of the ceramic tip of the resection sheath breaking have been received.	Class II	Olympus Corporation of the Americas
Nov 11, 2025	Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment...	Complaints of the ceramic tip of the resection sheath breaking have been received.	Class II	Olympus Corporation of the Americas
Nov 11, 2025	Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for ur...	Complaints of the ceramic tip of the resection sheath breaking have been received.	Class II	Olympus Corporation of the Americas
Nov 11, 2025	Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological ...	Complaints of the ceramic tip of the resection sheath breaking have been received.	Class II	Olympus Corporation of the Americas
Nov 11, 2025	Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041...	Complaints of the ceramic tip of the resection sheath breaking have been received.	Class II	Olympus Corporation of the Americas
Nov 11, 2025	Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treat...	Complaints of the ceramic tip of the resection sheath breaking have been received.	Class II	Olympus Corporation of the Americas
Nov 10, 2025	ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for c...	Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.	Class I	Draeger, Inc.
Nov 10, 2025	Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right,...	The device has been delivered with a preassembled locking screw that had been inserted from the w...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Nov 10, 2025	ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for condu...	Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.	Class I	Draeger, Inc.
Nov 10, 2025	ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for co...	Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.	Class I	Draeger, Inc.
Nov 10, 2025	ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for c...	Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.	Class I	Draeger, Inc.
Nov 10, 2025	COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For us...	Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts...	Class II	Beckman Coulter, Inc.
Nov 7, 2025	Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vin...	Due to a software implementation error that allowed instruments arms failing an important diagnos...	Class II	Intuitive Surgical, Inc.
Nov 7, 2025	Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety ...	IFU and device kit labeling contains misleading statements leading to improper securing of the de...	Class II	Rocket Medical Plc
Nov 7, 2025	Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tr...	IFU and device kit labeling contains misleading statements leading to improper securing of the de...	Class II	Rocket Medical Plc
Nov 7, 2025	Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tr...	IFU and device kit labeling contains misleading statements leading to improper securing of the de...	Class II	Rocket Medical Plc
Nov 7, 2025	Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety ...	IFU and device kit labeling contains misleading statements leading to improper securing of the de...	Class II	Rocket Medical Plc
Nov 7, 2025	Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tr...	IFU and device kit labeling contains misleading statements leading to improper securing of the de...	Class II	Rocket Medical Plc
Nov 7, 2025	Access 2 Reaction Vessels, individual, disposable, plastic tubes used to proc...	It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing d...	Class II	Beckman Coulter, Inc.
Nov 7, 2025	Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tr...	IFU and device kit labeling contains misleading statements leading to improper securing of the de...	Class II	Rocket Medical Plc
Nov 6, 2025	BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit R...	Labeling discrepancy; Ureteral stent actual size may not match the actual product label.	Class II	C.R. Bard Inc
Nov 6, 2025	BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD Alar...	Due to a number of modules flashed with a date and time associated with the daylight savings time...	Class II	CareFusion 303, Inc.
Nov 6, 2025	Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,	Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration pr...	Class II	Bard Peripheral Vascular Inc
Nov 6, 2025	BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit ...	Labeling discrepancy; Ureteral stent actual size may not match the actual product label.	Class II	C.R. Bard Inc
Nov 6, 2025	Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614	Labeling discrepancy; Ureteral stent actual size may not match the actual product label.	Class II	C.R. Bard Inc
Nov 6, 2025	MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)	Following a component change in the DPOAE probe (speaker replacement), technical distortions may ...	Class II	PATH
Nov 6, 2025	BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit R...	Labeling discrepancy; Ureteral stent actual size may not match the actual product label.	Class II	C.R. Bard Inc
Nov 5, 2025	Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for B...	Safety and efficacy of dialysis acid concentrate cannot be assured	Class II	Diasol, Inc
Nov 5, 2025	Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for B...	Safety and efficacy of dialysis acid concentrate cannot be assured	Class II	Diasol, Inc
Nov 5, 2025	Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be ...	Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign obje...	Class II	Accriva Diagnostics, Inc.
Nov 5, 2025	Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for B...	Safety and efficacy of dialysis acid concentrate cannot be assured	Class II	Diasol, Inc
Nov 5, 2025	Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for B...	Safety and efficacy of dialysis acid concentrate cannot be assured	Class II	Diasol, Inc
Nov 5, 2025	Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for B...	Safety and efficacy of dialysis acid concentrate cannot be assured	Class II	Diasol, Inc
Nov 5, 2025	Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for B...	Safety and efficacy of dialysis acid concentrate cannot be assured	Class II	Diasol, Inc
Nov 5, 2025	Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.	Product testing did not meet expected stability criteria.	Class II	Cepheid
Nov 4, 2025	Cardiosave Hybrid. Intra-Aortic Balloon Pump system.	The IFU addendum revises the Preventative Maintenance schedule to align with the update introduce...	Class II	Datascope Corp.
Nov 4, 2025	Cardiosave Rescue. Intra-Aortic Balloon Pump system.	The IFU addendum revises the Preventative Maintenance schedule to align with the update introduce...	Class II	Datascope Corp.
Nov 3, 2025	SQ40S Blood Transfusion Filter	Due to products being released for distribution prior to completion of the required quality contr...	Class II	GVS TM, Inc
Nov 3, 2025	Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System ...	Labeling contains claims that are not consistently present.	Class III	Orthofix U.S. LLC
Nov 3, 2025	Continuous Glucose Monitor (CGM)	Distribution without premarket approval/clearance.	Class II	GET TESTED INTERNATIONAL AB
Nov 3, 2025	Estrogen & Progesterone Test	Distribution without premarket approval/clearance.	Class II	GET TESTED INTERNATIONAL AB
Nov 3, 2025	Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer...	Labeling contains claims that are not consistently present.	Class III	Orthofix U.S. LLC
Nov 3, 2025	Gut Microbiome Test Medium	Distribution without premarket approval/clearance.	Class II	GET TESTED INTERNATIONAL AB
Nov 3, 2025	Vaginal PH Test	Distribution without premarket approval/clearance.	Class II	GET TESTED INTERNATIONAL AB
Nov 3, 2025	Environmental Pollutants Profile Test	Distribution without premarket approval/clearance.	Class II	GET TESTED INTERNATIONAL AB
Nov 3, 2025	Sorbitol Intolerance Test	Distribution without premarket approval/clearance.	Class II	GET TESTED INTERNATIONAL AB
Nov 3, 2025	IBS Test	Distribution without premarket approval/clearance.	Class II	GET TESTED INTERNATIONAL AB
Nov 3, 2025	Neurotransmitters XL	Distribution without premarket approval/clearance.	Class II	GET TESTED INTERNATIONAL AB

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.