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
Nov 14, 2025	Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lit...	Ongoing investigations identified additional instances of the device Generator remaining in a bli...	Class II	Olympus Corporation of the Americas
Nov 13, 2025	FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048	The items may have weak packaging seals that may result in a breach of sterility if the seal fail...	Class II	Medline Industries, LP
Nov 13, 2025	SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000	The items may have weak packaging seals that may result in a breach of sterility if the seal fail...	Class II	Medline Industries, LP
Nov 13, 2025	InPen App, Model/CFN Number: MMT-8061 (Android Users)	When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification St...	Class II	Medtronic MiniMed, Inc.
Nov 13, 2025	Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20	Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immun...	Class II	Abbott Laboratories
Nov 13, 2025	KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus der...	Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.	Class II	Microbiologics Inc
Nov 12, 2025	1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10...	Products may contain contamination, which may result in a darker or brown media color.	Class II	Remel, Inc
Nov 12, 2025	ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Co...	Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-l...	Class II	Cardinal Health 200, LLC
Nov 12, 2025	The Stryker CranialMask Tracker is a single-use device consisting of a flexib...	When the device is activated during surgery, the device software issues an error message "Instrum...	Class II	Howmedica Osteonics Corp.
Nov 11, 2025	Olympus Inner Sheath, Long; Model No. WA22017T. 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 Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatmen...	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. Model No. A22014A and A22014T. for endoscopic diagn...	Complaints of the ceramic tip of the resection sheath breaking have been received.	Class II	Olympus Corporation of the Americas
Nov 11, 2025	Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08	Devices are not suitable for organ transplant.	Class I	AVID Medical, Inc.
Nov 11, 2025	DEXLOCK Achilles Repair Implant Kits, MAKT4520	There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill gu...	Class II	Medline Industries, LP
Nov 11, 2025	Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for uro...	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; Model No. A22041A. Resection sheath for uro...	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 21 Fr. Model No. A2660T. for endoscopic diagnosis and t...	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. Model No. A2666T. for endoscopic diagnosis and tre...	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 Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. R...	Complaints of the ceramic tip of the resection sheath breaking have been received.	Class II	Olympus Corporation of the Americas
Nov 11, 2025	Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.	Devices are not suitable for organ transplant.	Class I	AVID Medical, Inc.
Nov 11, 2025	Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatmen...	Complaints of the ceramic tip of the resection sheath breaking have been received.	Class II	Olympus Corporation of the Americas
Nov 11, 2025	Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.	Devices are not suitable for organ transplant.	Class I	AVID Medical, Inc.
Nov 11, 2025	Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic appl...	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, 8 mm. Model No. A42011A. Resection sheath for gyne...	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, 26 Fr. with Deflecting Obturator; Model No. A22042T...	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 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

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.