http://www.fda.gov/ en http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/auromedics-pharma-llc-issues-voluntary-nationwide-recall-polymyxin-b-injection-usp-500000-unit-vial East Windsor, New Jersey, AuroMedics Pharma LLC has initiated a voluntary recall of lot number CPB200013 of Polymyxin B for Injection USP, 500,000 Units/Vial, to the consumer level from the USA market due to a product complaint for the presence of particulate matter, identified as hair being discove Fri, 28 Jan 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/auromedics-pharma-llc-issues-voluntary-nationwide-recall-polymyxin-b-injection-usp-500000-unit-vial http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blaine-labs-issues-voluntary-nationwide-recall-revitaderm-wound-care-gel-due-bacterial-contamination Blaine Labs Company is voluntarily recalling one lot of RevitaDerm Wound Care to the consumer level because a bottle of the 1.0 ounce RevitaDerm Wound Care Gel has been found to be contaminated with Bacillus cereus. Patients who apply the contaminated product to a wound could develop a skin and soft Thu, 27 Jan 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blaine-labs-issues-voluntary-nationwide-recall-revitaderm-wound-care-gel-due-bacterial-contamination http://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health This update provides additional information on the recall and recommendations for people who use repaired and replaced devices. Wed, 26 Jan 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-trilogy-evo-ventilators-potential-health-risks-pe-pur-foam Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam Wed, 26 Jan 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-trilogy-evo-ventilators-potential-health-risks-pe-pur-foam http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls List of Medical Device recalls in 2022. Wed, 26 Jan 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls http://www.fda.gov/medical-devices/safety-communications/philips-respironics-cpap-bipap-and-ventilator-recalls-frequently-asked-questions Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall Wed, 26 Jan 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/philips-respironics-cpap-bipap-and-ventilator-recalls-frequently-asked-questions http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-inc-recalls-hawkone-directional-atherectomy-system-due-risk-tip-damage-during-use This device is used during an atherectomy to treat patients who have calcified narrowings and blockages in the peripheral arteries. Fri, 21 Jan 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-inc-recalls-hawkone-directional-atherectomy-system-due-risk-tip-damage-during-use http://www.fda.gov/medical-devices/letters-health-care-providers/sodium-citrate-blood-specimen-collection-tube-conservation-strategies-letter-health-care-and Sodium Citrate Blood Specimen Collection Tube Conservation Strategies Wed, 19 Jan 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/letters-health-care-providers/sodium-citrate-blood-specimen-collection-tube-conservation-strategies-letter-health-care-and http://www.fda.gov/medical-devices/medical-device-recalls/getinge-usa-sales-llc-recalls-vaporizer-sevoflurane-maquet-filling-flow-family-anesthesia-systems Getinge USA Sales, LLC recalls its Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems due to a risk of harmful chemical exposure. Wed, 19 Jan 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/getinge-usa-sales-llc-recalls-vaporizer-sevoflurane-maquet-filling-flow-family-anesthesia-systems http://www.fda.gov/medical-devices/letters-health-care-providers/update-blood-specimen-collection-tube-conservation-strategies-letter-health-care-and-laboratory The FDA recommends conservation strategies to minimize the use of these tubes and maintain the quality and safety of care for patients. Wed, 19 Jan 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/letters-health-care-providers/update-blood-specimen-collection-tube-conservation-strategies-letter-health-care-and-laboratory http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-recall-one-batch-semgleer-insulin Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential f Wed, 19 Jan 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-recall-one-batch-semgleer-insulin http://www.fda.gov/medical-devices/safety-communications/update-risk-type-iii-endoleaks-use-endologix-afx-endovascular-aaa-graft-systems-fda-safety-0 Do not routinely use AFX2 endovascular grafts for patients with abdominal aortic aneurysms. Thu, 13 Jan 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/update-risk-type-iii-endoleaks-use-endologix-afx-endovascular-aaa-graft-systems-fda-safety-0 http://www.fda.gov/medical-devices/safety-communications/update-fda-reminds-patients-and-health-care-providers-importance-least-yearly-lifelong-follow-use The FDA is updating our October 28, 2019 safety communication on the use of AFX endovascular grafts with Duraply material (AFX with Duraply or AFX2). Thu, 13 Jan 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/update-fda-reminds-patients-and-health-care-providers-importance-least-yearly-lifelong-follow-use http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications Listing of Medical Device 2022 Safety Communications Thu, 13 Jan 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/oscor-inc-issues-voluntary-worldwide-recall-destino-twist-steerable-guiding-sheath-due-risk-device Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal on the proximal end of the devic Wed, 12 Jan 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/oscor-inc-issues-voluntary-worldwide-recall-destino-twist-steerable-guiding-sheath-due-risk-device http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lohxa-llc-issues-voluntary-nationwide-recall-senna-syrup-88mg5ml-due-microbial-contamination Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination. Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing li Wed, 12 Jan 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lohxa-llc-issues-voluntary-nationwide-recall-senna-syrup-88mg5ml-due-microbial-contamination http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0 Cranford, New Jersey, Viona Pharmaceuticals Inc., is voluntarily recalling thirty three (33) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. Reason for the recall is an Out of specification result observed for the said product, Lot number M008132, “N-nitroso Wed, 12 Jan 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0 http://www.fda.gov/safety/medical-product-safety-information/buprenorphine-drug-safety-communication-fda-warns-about-dental-problems-buprenorphine-medicines FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. Wed, 12 Jan 2022 00:00:00 EST FDA http://www.fda.gov/safety/medical-product-safety-information/buprenorphine-drug-safety-communication-fda-warns-about-dental-problems-buprenorphine-medicines http://www.fda.gov/medical-devices/safety-communications/stop-using-lusys-laboratories-covid-19-tests-fda-safety-communication The tests are likely to have a high risk of false results and are not FDA authorized, cleared, or approved. Tue, 11 Jan 2022 00:00:00 EST CDRH http://www.fda.gov/medical-devices/safety-communications/stop-using-lusys-laboratories-covid-19-tests-fda-safety-communication http://www.fda.gov/medical-devices/medical-device-recalls/cardiovascular-systems-inc-recalls-wirion-embolic-protection-device-due-complaints-filter-breakage Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval Mon, 10 Jan 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/cardiovascular-systems-inc-recalls-wirion-embolic-protection-device-due-complaints-filter-breakage