Browse Device Recalls

39 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39 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 39 FDA device recalls.

Clear

Date	Product	Reason	Class	Firm
Nov 18, 2025	Hardware configuration of the BeneVision Central Monitoring System (CMS), mar...	When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may...	Class II	Mindray DS USA, Inc. dba Mindray North America
Oct 20, 2025	Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labe...	Potential for anesthesia leakage.	Class II	Mindray DS USA, Inc. dba Mindray North America
Oct 20, 2025	Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. La...	Potential for anesthesia leakage.	Class II	Mindray DS USA, Inc. dba Mindray North America
Aug 15, 2025	BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA0001...	Potential for activation of an abnormal alarm pause.	Class II	Mindray DS USA, Inc. dba Mindray North America
Jul 22, 2024	Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provi...	V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jul 22, 2024	Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System...	V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jul 22, 2024	Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to prov...	V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jul 22, 2024	Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System...	V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo...	Class II	Mindray DS USA, Inc. dba Mindray North America
May 27, 2021	3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Tele...	Telepack may not power on when using the 3AA battery cradle.	Class III	Mindray DS USA, Inc. dba Mindray North America
Feb 22, 2021	Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 ...	BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jan 13, 2020	DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - ...	The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.	Class II	Mindray DS USA, Inc. dba Mindray North America
Dec 9, 2019	BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Cont...	The gas spring on the front and rear protective cover may fail. There is a low risk of injury to...	Class II	Mindray DS USA, Inc. dba Mindray North America
Dec 9, 2019	ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ...	The gas spring on the front and rear protective cover may fail. There is a low risk of injury to...	Class II	Mindray DS USA, Inc. dba Mindray North America
Oct 1, 2019	Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679...	NIBP valve assembly board subject to this recall includes enhancements that are not included in t...	Class II	Mindray DS USA, Inc. dba Mindray North America
Oct 1, 2019	Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00,...	NIBP valve assembly board subject to this recall includes enhancements that are not included in t...	Class II	Mindray DS USA, Inc. dba Mindray North America
Oct 1, 2019	Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00...	NIBP valve assembly board subject to this recall includes enhancements that are not included in t...	Class II	Mindray DS USA, Inc. dba Mindray North America
Oct 1, 2019	Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679...	NIBP valve assembly board subject to this recall includes enhancements that are not included in t...	Class II	Mindray DS USA, Inc. dba Mindray North America
Aug 30, 2018	Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00	The firm has identified performance anomalies with the device caused when more than 64 TD60 telem...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jan 24, 2018	Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: ...	Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluen...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jan 24, 2018	Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; P...	Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluen...	Class II	Mindray DS USA, Inc. dba Mindray North America
Dec 1, 2017	Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usa...	The firm made multiple changes to the product requiring the submission of a new 510(k) premarket ...	Class III	Mindray DS USA, Inc. dba Mindray North America
Jul 14, 2017	TD60 Transmitter battery charger used with the BeneVision Central Station, Pa...	A damaged circuit board in the battery charger can cause the battery to overcharge and the batter...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jul 14, 2017	A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3)...	A software issue may result in the previous settings being applied instead of the default setting...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jul 14, 2017	A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) ...	A software issue may result in the previous settings being applied instead of the default setting...	Class II	Mindray DS USA, Inc. dba Mindray North America
Apr 28, 2017	TI Transport Monitor/Module Battery Pack Product Usage: intended for moni...	Mindray has received two reports from outside the United States that the battery pack for TI tran...	Class II	Mindray DS USA, Inc. dba Mindray North America
Sep 8, 2016	TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics ...	Mindray has become aware that the TD60 Display Telemetry Transmitter used with the BeneVision Cen...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jun 23, 2016	Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring,...	Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jun 15, 2016	A7 Anesthesia Delivery System, a device used to administer to a patient, cont...	Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesi...	Class II	Mindray DS USA, Inc. dba Mindray North America
Mar 9, 2016	Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Mo...	Panorama Central Station including the work station View Station, View Station and the eGateway w...	Class II	Mindray DS USA, Inc. dba Mindray North America
Dec 15, 2015	Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View S...	An issue with the Panorama Central Station may cause the system to spontaneously restart. This ma...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jul 27, 2015	Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detec...	The DPM 7 Monitors may display a black screen.	Class II	Mindray DS USA, Inc. dba Mindray North America
Mar 12, 2015	Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with A...	Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is ...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jan 23, 2015	Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection ...	An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) whic...	Class II	Mindray DS USA, Inc. dba Mindray North America
Oct 6, 2014	DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the...	Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monito...	Class II	Mindray DS USA, Inc. dba Mindray North America
Jul 31, 2014	Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 ...	Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor be...	Class II	Mindray DS USA, Inc. dba Mindray North America
May 19, 2014	V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. ...	ECG interpretation feature issues. False measurements reported when the algorithm cannot determi...	Class II	Mindray DS USA, Inc. dba Mindray North America
Mar 5, 2014	DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor us...	The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.	Class II	Mindray DS USA, Inc. dba Mindray North America
Jan 8, 2014	Panaroma Central Station Product Usage: This device can view real time,...	Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag...	Class II	Mindray DS USA, Inc. dba Mindray North America
Oct 7, 2013	Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) P...	Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the ...	Class II	Mindray DS USA, Inc. dba Mindray North America

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.