http://www.fda.gov/ en http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medline-industries-lp-issues-nationwide-recall-subg-endotracheal-tube-subglottic-suction On February 20, 2024, Medline Industries, LP initiated a nationwide recall of 6 SubG Endotracheal Tubes with Subglottic Suction and 10 kits that contain these devices. The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, l Fri, 31 May 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medline-industries-lp-issues-nationwide-recall-subg-endotracheal-tube-subglottic-suction http://www.fda.gov/medical-devices/medical-device-recalls/2024-medical-device-recalls 2024 Medical Device Recalls Thu, 30 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/optumhealth-care-solutions-recalls-nimbus-ii-infusion-pump-systems-under-recall-infutronix-llc Nimbus II infusion pumps may experience one or more issues that can cause severe patient injury and death. Thu, 30 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/optumhealth-care-solutions-recalls-nimbus-ii-infusion-pump-systems-under-recall-infutronix-llc http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-issues-voluntary-nationwide-recall-docetaxel-injection-usp-due-potential Sagent Pharmaceuticals today announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The product was distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Docetaxel Injec Wed, 29 May 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-issues-voluntary-nationwide-recall-docetaxel-injection-usp-due-potential http://www.fda.gov/medical-devices/medical-device-recalls/vyaire-medical-inc-recalls-twin-tube-due-potential-nozzle-separating-during-patient-use Vyaire Medical recalls Twin Tube due to potential nozzle separation risk posing a choking hazard. Thu, 23 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/vyaire-medical-inc-recalls-twin-tube-due-potential-nozzle-separating-during-patient-use 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, 23 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/safety-communications/biozorb-markers-and-potential-risks-use-breast-tissue-fda-safety-communication FDA is informing the public of adverse events reported with the use of BioZorb Marker including pain, migration, erosion, and others. Wed, 22 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/biozorb-markers-and-potential-risks-use-breast-tissue-fda-safety-communication http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-buprenorphine-hydrochloride-injection-carpujecttm Hospira, Inc., a Pfizer company (“Pfizer”), is voluntarily recalling the lots listed in the table below of Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units to the User level. The recall was initiated due to the potential for incompl Wed, 22 May 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-buprenorphine-hydrochloride-injection-carpujecttm http://www.fda.gov/medical-devices/medical-device-recalls/hologic-inc-recalls-biozorb-marker-due-complications-implanted-devices Hologic, Inc. is recalling BioZorb Marker due to complications and adverse events with implanted devices. Wed, 22 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/hologic-inc-recalls-biozorb-marker-due-complications-implanted-devices 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/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/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/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/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