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Browse Device Recalls

78 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 78 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 78 FDA device recalls.

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DateProductReasonClassFirm
Dec 21, 2018 ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
Dec 21, 2018 VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia S... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
Dec 21, 2018 VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Ane... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
Dec 21, 2018 ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesi... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
May 24, 2018 Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a... The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... Class II Draeger Medical, Inc.
May 24, 2018 Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalat... The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... Class II Draeger Medical, Inc.
May 24, 2018 Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inh... The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... Class II Draeger Medical, Inc.
May 24, 2018 Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhala... The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... Class II Draeger Medical, Inc.
May 24, 2018 Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usa... The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... Class II Draeger Medical, Inc.
Apr 26, 2018 Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator f... The valve assembly material may become corroded due to insufficient cleaning by a supplier. There... Class II Draeger Medical, Inc.
Mar 1, 2018 Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The... The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... Class I Draeger Medical, Inc.
Mar 1, 2018 Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The p... The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... Class I Draeger Medical, Inc.
Mar 1, 2018 Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: ... The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... Class I Draeger Medical, Inc.
Mar 1, 2018 Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The pr... The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... Class I Draeger Medical, Inc.
Jun 22, 2016 Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog #... Risk associated with operating the device in skin temperature mode with temperature sensors attac... Class II Draeger Medical, Inc.
May 31, 2016 Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 ... Isolated episodes of leakage at the check valve were found Class I Draeger Medical, Inc.
Apr 21, 2016 Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bot... Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling proc... Class II Draeger Medical, Inc.
Feb 4, 2016 Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation. The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation C... Class I Draeger Medical, Inc.
Dec 22, 2015 Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus V... Drager became aware of situations where the error message "Poti unplugged" was generated causing ... Class I Draeger Medical, Inc.
Dec 22, 2015 Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: ... Drager became aware of situations where the error message "Poti unplugged" was generated causing ... Class I Draeger Medical, Inc.
Dec 1, 2015 Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN... The firm became aware of cases in which the battery run times of the optional PS 500 power supply... Class I Draeger Medical, Inc.
Nov 12, 2015 Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthet... There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Wor... Class I Draeger Medical, Inc.
Jul 13, 2015 PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended fo... The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V... Class I Draeger Medical, Inc.
Jun 22, 2015 Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine... the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fab... Class II Draeger Medical, Inc.
Mar 25, 2014 Reusable latex breathing bags with multiple part numbers and sold as part of ... Reusable latex breathing bags with various part numbers and sold as part of test lung and reusabl... Class II Draeger Medical, Inc.
Sep 30, 2013 Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in ... Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive... Class II Draeger Medical, Inc.
Aug 14, 2013 Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product... During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia mach... Class I Draeger Medical, Inc.
Dec 13, 2012 Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number... The displayed value for the invasive blood pressure measurement of the IACS was different than th... Class II Draeger Medical, 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.