http://www.fda.gov/ en http://www.fda.gov/medical-devices/medical-device-recalls/north-american-diagnostics-recalls-oral-rapid-sars-cov-2-rapid-antigen-test-kits-are-not-authorized North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits because they are not authorized, cleared, or approved by the FDA. Mon, 01 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/north-american-diagnostics-recalls-oral-rapid-sars-cov-2-rapid-antigen-test-kits-are-not-authorized http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls List of Medical Device recalls in 2022. Mon, 01 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/edgewell-personal-care-issues-voluntary-nationwide-recall-banana-boat-hair-scalp-sunscreen-due Edgewell Personal Care Company (NYSE: EPC) today issued a voluntary nationwide recall of three batches of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 to the consumer level as outlined in the table below. An internal review found that some samples of the product contained trace levels of benzen Fri, 29 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/edgewell-personal-care-issues-voluntary-nationwide-recall-banana-boat-hair-scalp-sunscreen-due http://www.fda.gov/medical-devices/medical-device-recalls/covidien-llc-medtronic-recalls-palindrome-and-mahurkar-hemodialysis-catheters-due-catheter-hub Covidien, LLC (Medtronic) is recalling Palindrome and Mahurkar hemodialysis catheters due to catheter hub defect. Thu, 28 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/covidien-llc-medtronic-recalls-palindrome-and-mahurkar-hemodialysis-catheters-due-catheter-hub http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-nationwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate July 25, 2022 – Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry to the consumer level. This expansion includes all lots of Cherry Flavor and Grape Flavor of Magnesium Citrate Saline Laxati Tue, 26 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-nationwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/loud-muscle-science-llc-issues-voluntary-recall-launch-sequence-capsules-due-presence-undeclared Hauppauge, NY, Loud Muscle Science, LLC is voluntarily recalling the following Launch Sequence products and lots listed in the table below to the consumer level. Laboratory analysis undertaken at the request of Loud Muscle Science, LLC found the products to be tainted with tadalafil, an ingredient i Tue, 26 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/loud-muscle-science-llc-issues-voluntary-recall-launch-sequence-capsules-due-presence-undeclared http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ultra-supplement-llc-issues-voluntary-nationwide-recall-sustango-due-presence-undeclared-tadalafil Wilmington DE, Ultra Supplement LLC is voluntarily recalling lot number DAP272109, exp 4/1/26 of Sustango capsules packaged in 10-count blisters packaged in a carton to the consumer level. Ultra Supplement was notified by Amazon that laboratory analysis has found the product to be tainted with tadal Mon, 25 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ultra-supplement-llc-issues-voluntary-nationwide-recall-sustango-due-presence-undeclared-tadalafil http://www.fda.gov/medical-devices/medical-device-recalls/baxter-healthcare-corporation-recalls-abacus-order-entry-and-calculation-software-risk-medication User changes in the Abacus order entry and calculation software labeling templates may cause incorrect information to appear on final medication labels. Mon, 25 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/baxter-healthcare-corporation-recalls-abacus-order-entry-and-calculation-software-risk-medication 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, 21 Jul 2022 00:00:00 EDT 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/update-use-renuvionj-plasma-device-certain-aesthetic-procedures-fda-safety-communication Renuvion/J-Plasma device can be used for additional aesthetic skin procedures Thu, 21 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/update-use-renuvionj-plasma-device-certain-aesthetic-procedures-fda-safety-communication http://www.fda.gov/medical-devices/safety-communications/update-fda-updates-recommendations-use-renuvionj-plasma-device-certain-aesthetic-procedures-fda Renuvion/J-Plasma device with new handpiece can be used for certain aesthetic skin procedures. Thu, 21 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/update-fda-updates-recommendations-use-renuvionj-plasma-device-certain-aesthetic-procedures-fda http://www.fda.gov/medical-devices/safety-communications/fda-warns-against-use-renuvionj-plasma-device-certain-aesthetic-procedures-fda-safety-communication Renuvion/J-Plasma has not been cleared for Aesthetic Skin Procedures. FDA warns patients & health care providers of potential risks. Thu, 21 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/fda-warns-against-use-renuvionj-plasma-device-certain-aesthetic-procedures-fda-safety-communication http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications Listing of Medical Device 2022 Safety Communications Thu, 21 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-recall-certain-over-counter-products Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022 due to product being stored outside of labeled Thu, 21 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-recall-certain-over-counter-products http://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-recalls-certain-medfusion-3500-and-4000-syringe-infusion-pumps-software-issues-may Software issues affecting certain Medfusion Syringe Infusion Pumps could impact infusion delivery to patients. Wed, 20 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-recalls-certain-medfusion-3500-and-4000-syringe-infusion-pumps-software-issues-may http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mks-enterprise-llc-voluntary-recalls-dose-vital-vip-vital-honey-due-presence-undeclared-tadalafil This product was found to contain the undeclared active pharmaceutical ingredient tadalafil. Tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor, is the active ingredient in an FDA-approved prescription drug, used to treat erectile dysfunction (ED). This undeclared ingredient may intera Tue, 19 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mks-enterprise-llc-voluntary-recalls-dose-vital-vip-vital-honey-due-presence-undeclared-tadalafil http://www.fda.gov/medical-devices/safety-communications/monkeypox-testing-use-lesion-swab-samples-avoid-false-results-fda-safety-communication Monkeypox testing of saliva, blood, or other sample types may have false results Fri, 15 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/monkeypox-testing-use-lesion-swab-samples-avoid-false-results-fda-safety-communication http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-nationwide-recall-magnesium-citrate-saline-laxative-oral-solution-lemon Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry to the consumer level. The recall was initiated after 3rd Party and Vi-Jon, LLC microbial testing identified the presence of Fri, 15 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-nationwide-recall-magnesium-citrate-saline-laxative-oral-solution-lemon http://www.fda.gov/medical-devices/medical-device-recalls/american-contract-systems-recalls-covid-test-kits-nonsterile-and-clean-catch-urine-kits-risk-false COVID testing or specimen kits for urine samples may not give accurate results because they were assembled in an uncontrolled facility by people without proper training. Thu, 14 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/american-contract-systems-recalls-covid-test-kits-nonsterile-and-clean-catch-urine-kits-risk-false http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-issues-voluntary-nationwide-recall-one-lot-propofol-injectable-emulsion-usp-containing Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol) to the user level due to a visible particulate observed in a single vial during annual examination of retain samples Wed, 13 Jul 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-issues-voluntary-nationwide-recall-one-lot-propofol-injectable-emulsion-usp-containing