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
Dec 23, 2024	CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System ma...	Snap rings may become partially or completed detached from the shafts within the internal mechani...	Class II	Accuray Incorporated
Aug 3, 2023	Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for ...	It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide e...	Class II	Accuray Incorporated
Feb 26, 2021	CyberKnife Treatment Delivery System - Product Usage: indicated for image-gui...	The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen...	Class II	Accuray Incorporated
Dec 10, 2020	TomoTherapy Treatment System - Product Usage: used as an integrated system fo...	"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.	Class II	Accuray Incorporated
Dec 10, 2020	TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an i...	"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.	Class II	Accuray Incorporated
Sep 26, 2018	CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indic...	A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-l...	Class II	Accuray Incorporated
Aug 31, 2018	Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is ...	the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and ma...	Class II	Accuray Incorporated
Apr 10, 2018	CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic R...	There is an unintended drop of a secondary collimator housing that can occur during housing Xchan...	Class II	Accuray Incorporated
Apr 10, 2018	CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery Syste...	There is an unintended drop of a secondary collimator housing that can occur during housing Xchan...	Class II	Accuray Incorporated
Nov 17, 2017	Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy ...	Uncontrolled couch Z-axis movement (descent)	Class II	Accuray Incorporated
Nov 17, 2017	TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy tre...	Uncontrolled couch Z-axis movement (descent)	Class II	Accuray Incorporated
Nov 17, 2017	TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy trea...	Uncontrolled couch Z-axis movement (descent)	Class II	Accuray Incorporated
Nov 17, 2017	TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy tr...	Uncontrolled couch Z-axis movement (descent)	Class II	Accuray Incorporated
Dec 6, 2016	CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: T...	Accuray has become aware of a potential safety issue involving the possibility of electric shock ...	Class II	Accuray Incorporated
Nov 22, 2016	CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/...	Accuray has become aware of a potential safety issue involving unexpected treatment robot motion ...	Class II	Accuray Incorporated
Jan 22, 2016	CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover pack...	The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inve...	Class II	Accuray Incorporated
Oct 31, 2014	CyberKnife Robotic Radiosurgery System with the first generation IRIS Variabl...	Software upgrade to correct potential safety issue related to CyberKnife System that occurs when ...	Class II	Accuray Incorporated
Jan 13, 2014	Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyval...	Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting asse...	Class II	Accuray Incorporated
Mar 27, 2013	RoboCouch Patient Positioning System Product Usage: is intended for use...	A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) moti...	Class II	Accuray Incorporated
Mar 19, 2013	Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Med...	A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt ...	Class II	Accuray Incorporated

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.