http://www.fda.gov/ en http://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication Thu, 16 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication http://www.fda.gov/medical-devices/medical-device-recalls/draeger-inc-recalls-perseus-a500-anesthesia-system-risk-sudden-unexpected-shutdown-when-used-battery The Perseus A500 that provides anesthesia and/or ventilation during surgical or diagnostic procedures may unexpectedly shutdown while using battery power. Wed, 15 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/draeger-inc-recalls-perseus-a500-anesthesia-system-risk-sudden-unexpected-shutdown-when-used-battery http://www.fda.gov/medical-devices/medical-device-recalls/biomerieux-inc-recalls-vitek-2-ast-kit-due-incorrect-ceftriaxone-concentrations BioMérieux is recalling their VITEK 2 AST cards, used for testing bacterial sensitivity to antibiotics, due to excessive Ceftriaxone in two wells. Wed, 15 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/biomerieux-inc-recalls-vitek-2-ast-kit-due-incorrect-ceftriaxone-concentrations http://www.fda.gov/medical-devices/medical-device-recalls/2024-medical-device-recalls 2024 Medical Device Recalls Wed, 15 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/2024-medical-device-recalls http://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-heartmate-3-left-ventricular-assist-system-lvas-implant-kit-risk-blood-leakage-or-air The HeartMate 3 Left Ventricular Assist System may allow blood to leak out or air to enter the system during implant of the LVAD device. Wed, 15 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-heartmate-3-left-ventricular-assist-system-lvas-implant-kit-risk-blood-leakage-or-air http://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication The FDA issues alert about risk of false results with Cue Health’s COVID-19 Tests due to modifications made without FDA authorization that have a strong likelihood to impact performance. Mon, 13 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication http://www.fda.gov/medical-devices/safety-communications/2024-safety-communications Listing of Medical Device 2024 Safety Communications Mon, 13 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2024-safety-communications http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-inc-recalls-trilogy-evo-continuous-ventilators-due-software-related-possible Philips Respironics is recalling their Trilogy Evo ventilators due to a software-related possible power malfunction, leading to a sudden loss of ventilation. Mon, 13 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-inc-recalls-trilogy-evo-continuous-ventilators-due-software-related-possible http://www.fda.gov/medical-devices/medical-device-recalls/route-92-medical-inc-recalls-catheter-due-distal-tip-separation-proximal-marker-band Route 92 Medical is recalling certain products that include Tenzing 7 Delivery Catheters due to instances of the catheter tip separating near the marker band. Fri, 10 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/route-92-medical-inc-recalls-catheter-due-distal-tip-separation-proximal-marker-band http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadynetm-initiates-global-discontinuation-and-voluntary-recall-mega-softtm-pediatric-patient MEGADYNE™ is initiating a voluntary recall of all MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrodes. The product is being removed because Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A root cause investigation on Fri, 10 May 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadynetm-initiates-global-discontinuation-and-voluntary-recall-mega-softtm-pediatric-patient http://www.fda.gov/medical-devices/medical-device-recalls/tandem-diabetes-care-inc-recalls-version-27-apple-ios-tconnect-mobile-app-used-conjunction-tslim-x2 Tandem Diabetes Care, Inc. recalls t:connect mobile app (v2.7) for t:slim X2 insulin pump due to software issue that may cause app to crash and deplete pump battery Wed, 08 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/tandem-diabetes-care-inc-recalls-version-27-apple-ios-tconnect-mobile-app-used-conjunction-tslim-x2 http://www.fda.gov/medical-devices/letters-health-care-providers/2024-letters-health-care-providers The FDA posts letters to health care providers about the safe use of medical devices. Wed, 08 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/2024-letters-health-care-providers http://www.fda.gov/medical-devices/letters-health-care-providers/getingemaquet-cardiohelp-system-potential-insufficient-packaging-sterility-hls-set-advanced-letter Learn more about the issue with the HLS Set Advanced, background, FDA recommendations and FDA actions Wed, 08 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/getingemaquet-cardiohelp-system-potential-insufficient-packaging-sterility-hls-set-advanced-letter http://www.fda.gov/medical-devices/letters-health-care-providers/update-risk-device-failures-getinges-maquetdatascope-cardiosave-intra-aortic-balloon-pump-iabp Cardiosave IABP devices may unexpectedly shutdown or interrupt therapy (pump stops). Wed, 08 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/update-risk-device-failures-getinges-maquetdatascope-cardiosave-intra-aortic-balloon-pump-iabp http://www.fda.gov/medical-devices/letters-health-care-providers/oxygenator-devices-used-extracorporeal-circulation-letter-health-care-providers Learn about the issue, the FDA's recommendations and actions, how to report a problem, and contact information. Wed, 08 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/oxygenator-devices-used-extracorporeal-circulation-letter-health-care-providers http://www.fda.gov/medical-devices/letters-health-care-providers/safety-and-quality-concerns-getinge-cardiovascular-devices-letter-health-care-providers Health care providers and facilities should begin to transition away from these devices and seek alternatives. Wed, 08 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/safety-and-quality-concerns-getinge-cardiovascular-devices-letter-health-care-providers http://www.fda.gov/medical-devices/medical-device-recalls/sonarmed-inc-recalls-airway-acoustic-sensors-due-restricted-inner-diameter-airway-causing-suction SonarMed Airway acoustic sensors recalled due to a restricted inner diameter resulting in difficulty passing a suction catheter through the sensor. Mon, 29 Apr 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/sonarmed-inc-recalls-airway-acoustic-sensors-due-restricted-inner-diameter-airway-causing-suction http://www.fda.gov/medical-devices/medical-device-recalls/sonarmed-inc-recalls-airway-monitors-due-software-anomaly-resulting-failure-detect-partial SonarMed Airway monitors recalled for a software issue where it fails to detect partial obstructions in 2.5mm sensors and within 3mm of sensor tip. Mon, 29 Apr 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/sonarmed-inc-recalls-airway-monitors-due-software-anomaly-resulting-failure-detect-partial http://www.fda.gov/medical-devices/safety-communications/fda-encourages-public-follow-established-choking-rescue-protocols-fda-safety-communication These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices. Fri, 26 Apr 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/fda-encourages-public-follow-established-choking-rescue-protocols-fda-safety-communication http://www.fda.gov/medical-devices/medical-device-recalls/elekta-instrument-ab-recalls-disposable-biopsy-needle-kit-leksell-stereotactic-system-possibly Elekta recalls Disposable Biopsy Needles (911933) from batch 837838839 due to potential microscopic stainless steel debris inside. Fri, 26 Apr 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/elekta-instrument-ab-recalls-disposable-biopsy-needle-kit-leksell-stereotactic-system-possibly