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Browse Device Recalls

30 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 30 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 30 FDA device recalls.

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DateProductReasonClassFirm
Dec 15, 2017 Camera System, Television, Surgical without audio Intended for transmissio... The radiated emission from the TruVidia" Wireless Receiver is above the normative accepted limits... Class II Trumpf Medical Systems, Inc.
Oct 25, 2016 OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 19097... Trumpf has identified six incidents of pinched cables. Class II Trumpf Medical Systems, Inc.
Jul 10, 2016 Stationary Column TruSystem 7599, Material Number 1717020 Patient position... Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. Class II Trumpf Medical Systems, Inc.
Jul 10, 2016 Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Colu... Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. Class II Trumpf Medical Systems, Inc.
Jul 10, 2016 Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSyste... Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. Class II Trumpf Medical Systems, Inc.
Jul 10, 2016 Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table Tr... Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. Class II Trumpf Medical Systems, Inc.
Jan 19, 2016 Patient transport Shuttle with Trendelenburg quick adjustment function (Jupit... Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a... Class II Trumpf Medical Systems, Inc.
Nov 2, 2015 Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted ... The firm has received 15 complaints over ten years related to the connection of the spring arm to... Class II Trumpf Medical Systems, Inc.
Jul 27, 2015 Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #14... Complaints received of the front joint of the spring arm AC 2000 could break at the interface to ... Class II Trumpf Medical Systems, Inc.
Jul 27, 2015 Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #15... Complaints received of the front joint of the spring arm AC 2000 could break at the interface to ... Class II Trumpf Medical Systems, Inc.
Jul 27, 2015 Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #15589... Complaints received of the front joint of the spring arm AC 2000 could break at the interface to ... Class II Trumpf Medical Systems, Inc.
Jul 27, 2015 Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Man... Complaints received of the front joint of the spring arm AC 2000 could break at the interface to ... Class II Trumpf Medical Systems, Inc.
Jul 27, 2015 Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Ma... Complaints received of the front joint of the spring arm AC 2000 could break at the interface to ... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) ... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.)... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (i... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 10... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.)... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (inc... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 IR remote control JUX, Material no.1307314, Serial number: to (incl.) 1023383... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 1012... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 (R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) ... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Oct 9, 2014 TITAN Operating Room Table Patient positioning during surgery, ranging fro... Unintended movement of the operating table during surgical cases due to the use of damaged TITAN ... Class II Trumpf Medical Systems, Inc.
Oct 28, 2013 TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU Use of t... The coupler point (hood) of the Leg Section One Part Light may become detached from the leg secti... Class II Trumpf Medical Systems, Inc.
Feb 19, 2013 Helion S Exam Light or H300 The device is intended to locally illuminate a... Possible fatigue failure of the plastic joint may occur after an average use of seven years. Class II Trumpf Medical Systems, Inc.
Sep 19, 2012 Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical... Incidents regarding fractures of the front joint of the spring arm have been reported. Class II Trumpf Medical Systems, Inc.
May 29, 2012 Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TR... Cracks can arise on the welded seam on the rear joint. Class II Trumpf Medical Systems, 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.