http://www.fda.gov/ en http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-initiates-voluntary-nationwide-recall-specific-lots-fentanyl-buccal-tablets-cii-due-labeling Teva Pharmaceuticals USA, has initiated a voluntary nationwide recall of specific lots of various strengths of FENTANYL Buccal Tablets CII to the Consumer Level. Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label. This recall has been initiated Fri, 28 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-initiates-voluntary-nationwide-recall-specific-lots-fentanyl-buccal-tablets-cii-due-labeling http://www.fda.gov/medical-devices/letters-health-care-providers/illumina-cybersecurity-vulnerability-affecting-universal-copy-service-software-may-present-risks Illumina cybersecurity vulnerability affecting the Universal Copy Service software may impact patient health results. Thu, 27 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/illumina-cybersecurity-vulnerability-affecting-universal-copy-service-software-may-present-risks http://www.fda.gov/medical-devices/letters-health-care-providers/2023-letters-health-care-providers The FDA posts letters to health care providers about the safe use of medical devices. Thu, 27 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/2023-letters-health-care-providers http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gear-isle-issues-voluntary-nationwide-recall-pro-power-knight-plus-nux-male-enhancement-and-dynamite West Sacramento, CA, Gear Isle is voluntarily recalling the following products listed in the table below to the consumer level. FDA analysis has found the products to be tainted with sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as Phosphodiesterase Inhibitors (PDE-5) inhi Wed, 26 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gear-isle-issues-voluntary-nationwide-recall-pro-power-knight-plus-nux-male-enhancement-and-dynamite http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/akorn-issues-voluntary-nationwide-recall-various-human-and-animal-drug-products-within-expiry-due Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various w Wed, 26 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/akorn-issues-voluntary-nationwide-recall-various-human-and-animal-drug-products-within-expiry-due http://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-inc-recalls-certain-ballard-access-closed-suction-systems-neonatespediatrics-risk A cracked manifold on some BALLARD ACCESS Closed Suction Systems may cause inadequate ventilation or other injury to vulnerable patients. Fri, 21 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-inc-recalls-certain-ballard-access-closed-suction-systems-neonatespediatrics-risk http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls 2023 Medical Device Recalls Fri, 21 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls http://www.fda.gov/medical-devices/safety-communications/risk-protection-failure-certain-om-halyard-surgical-n95-respirators-surgical-masks-and-pediatric Certain surgical respirators, surgical masks, and pediatric face masks by O&M Halyard do not meet quality and performance expectations. Fri, 21 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/risk-protection-failure-certain-om-halyard-surgical-n95-respirators-surgical-masks-and-pediatric http://www.fda.gov/medical-devices/medical-device-recalls/fresenius-kabi-usa-llc-recalls-ivenix-infusion-system-fluid-leak-may-delay-or-interrupt-treatment Fluid leaking into the Ivenix Infusion System may prevent the pump from delivering fluid or stop working before therapy is finished. Wed, 19 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/fresenius-kabi-usa-llc-recalls-ivenix-infusion-system-fluid-leak-may-delay-or-interrupt-treatment http://www.fda.gov/safety/medical-product-safety-information/all-opioid-pain-medicines-drug-safety-communication-fda-updates-prescribing-information-provide FDA is requiring several updates to the prescribing information for both immediate-release (IR) and extended release/long acting (ER/LA) opioid pain medicines. The FDA is adding a new warning about opioid-induced hyperalgesia. Thu, 13 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/safety/medical-product-safety-information/all-opioid-pain-medicines-drug-safety-communication-fda-updates-prescribing-information-provide http://www.fda.gov/medical-devices/safety-communications/faqs-philips-respironics-ventilator-bipap-machine-and-cpap-machine-recalls Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall Thu, 13 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/faqs-philips-respironics-ventilator-bipap-machine-and-cpap-machine-recalls http://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due This update provides additional information on the recall and recommendations for people who use repaired and replaced devices. Thu, 13 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due http://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-readers-used-freestyle-libre-freestyle-libre-14-day-and-freestyle-libre-2-flash The readers that are part of FreeStyle Libre Glucose Monitoring Systems may grow extremely hot or catch on fire, posing significant risk to users. Wed, 12 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-readers-used-freestyle-libre-freestyle-libre-14-day-and-freestyle-libre-2-flash http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications Listing of Medical Device 2023 Safety Communications Wed, 12 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-reworked-dreamstation-cpap-bipap-machines-risk-they-may-deliver Certain Philips Respironics DreamStation CPAP and BiPAP Machines are recalled because they may not deliver the right correct amount of breathing support. Fri, 07 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-reworked-dreamstation-cpap-bipap-machines-risk-they-may-deliver http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-issues-safety-notification-freestyle-librer-family-readers-us Abbott initiated a voluntary medical device correction in February to emphasize instructions for its FreeStyle Libre®, FreeStyle Libre® 14 day and FreeStyle Libre® 2 Readers in the United States due to a limited number of reports worldwide (0.0017%) from users over several years that their reader’s Mon, 03 Apr 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-issues-safety-notification-freestyle-librer-family-readers-us http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product. : In the population most at risk, immunocompromised population, there is a reasonable proba Fri, 31 Mar 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp http://www.fda.gov/medical-devices/medical-device-recalls/recall-datascopegetinge-certain-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabp-risk Communication loss between Executive Processor and Video Generator PCBAs may cause unexpected shutdown, interrupting therapy to the patient with no warning. Fri, 31 Mar 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/recall-datascopegetinge-certain-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabp-risk http://www.fda.gov/medical-devices/safety-communications/evaluation-safety-concerns-certain-dental-devices-used-adults-fda-safety-communication Certain dental devices have not been cleared or approved by the FDA. Thu, 30 Mar 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/evaluation-safety-concerns-certain-dental-devices-used-adults-fda-safety-communication http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-jarmans-midwest-cleaning-systems-inc-issues-voluntary-nationwide-recall-alcohol-antiseptic Canton, SD, Jarman’s Midwest Cleaning Systems, Inc. is voluntarily recalling all lots of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution to the consumer level. FDA testing found the Tue, 28 Mar 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-jarmans-midwest-cleaning-systems-inc-issues-voluntary-nationwide-recall-alcohol-antiseptic