Browse Device Recalls

20 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 20 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 20 FDA device recalls.

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Date	Product	Reason	Class	Firm
Apr 26, 2024	O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and ...	Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,...	Class II	Medtronic Navigation, Inc.-Littleton
Jul 25, 2023	The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluorosc...	Ground cable installed incorrectly.	Class II	Medtronic Navigation, Inc.-Littleton
Nov 15, 2019	O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000	Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determ...	Class II	Medtronic Navigation, Inc.-Littleton
May 1, 2019	Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XX...	The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the syst...	Class II	Medtronic Navigation, Inc.-Littleton
Sep 17, 2018	Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ra...	O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and...	Class II	Medtronic Navigation, Inc.-Littleton
Aug 30, 2018	O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GE...	Software anomalies were reported to affect the following system functionalities: startup and shut...	Class II	Medtronic Navigation, Inc.-Littleton
Aug 30, 2018	O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, M...	Software anomalies were reported to affect the following system functionalities: startup and shut...	Class II	Medtronic Navigation, Inc.-Littleton
Aug 30, 2018	O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, M...	Software anomalies were reported to affect the following system functionalities: startup and shut...	Class II	Medtronic Navigation, Inc.-Littleton
Aug 30, 2018	O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV R...	Software anomalies were reported to affect the following system functionalities: startup and shut...	Class II	Medtronic Navigation, Inc.-Littleton
Aug 30, 2018	O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, M...	Software anomalies were reported to affect the following system functionalities: startup and shut...	Class II	Medtronic Navigation, Inc.-Littleton
Aug 30, 2018	O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 1...	Software anomalies were reported to affect the following system functionalities: startup and shut...	Class II	Medtronic Navigation, Inc.-Littleton
Aug 30, 2018	O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V R...	Software anomalies were reported to affect the following system functionalities: startup and shut...	Class II	Medtronic Navigation, Inc.-Littleton
Aug 30, 2018	O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT R...	Software anomalies were reported to affect the following system functionalities: startup and shut...	Class II	Medtronic Navigation, Inc.-Littleton
Aug 30, 2018	O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK,...	Software anomalies were reported to affect the following system functionalities: startup and shut...	Class II	Medtronic Navigation, Inc.-Littleton
Aug 30, 2018	O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, M...	Software anomalies were reported to affect the following system functionalities: startup and shut...	Class II	Medtronic Navigation, Inc.-Littleton
Jan 25, 2018	O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BAS...	Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inabili...	Class II	Medtronic Navigation, Inc.-Littleton
Sep 30, 2017	O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02...	During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is po...	Class II	Medtronic Navigation, Inc.-Littleton
Sep 22, 2016	Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number:...	O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigate...	Class II	Medtronic Navigation, Inc.-Littleton
Mar 17, 2016	Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027,...	It has been discovered that replacement x-ray generator and system motion batteries could become ...	Class II	Medtronic Navigation, Inc.-Littleton
Mar 17, 2016	Medtronic Navigation O-arm 02 surgical x-ray imaging system	Review of on-system electronic product labeling and Instr uctions for Use in response to an inter...	Class II	Medtronic Navigation, Inc.-Littleton

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.