MedWatch Safety Alerts RSS Feed http://www.fda.gov/ en 2022 Medical Device Recalls http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls List of Medical Device recalls in 2022. Thu, 11 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls 2022 Safety Communications http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications Listing of Medical Device 2022 Safety Communications Thu, 11 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications Becton Dickinson Recalls Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers for Issues That May Cause Delayed Treatment Delivery http://www.fda.gov/medical-devices/medical-device-recalls/becton-dickinson-recalls-intraosseous-needle-set-kits-intraosseous-manual-driver-kits-and Issues with BD Intraosseous needle kits and drivers may prevent treatments from being infused through the bone causing delays in care. Thu, 11 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/becton-dickinson-recalls-intraosseous-needle-set-kits-intraosseous-manual-driver-kits-and At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication http://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-fda-safety-communication The FDA recommends repeat testing following a negative result to reduce the risk that a COVID-19 infection could be missed, whether or not you have symptoms. Thu, 11 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-fda-safety-communication Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA http://www.fda.gov/medical-devices/medical-device-recalls/haimen-shengbang-laboratory-equipment-co-ltd-recalls-viral-transport-media-containers-are-not Haimen Shengbang is recalling Viral Transport Media Containers because they were distributed to U.S. customers without FDA authorization, clearance, or approval. Tue, 09 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/haimen-shengbang-laboratory-equipment-co-ltd-recalls-viral-transport-media-containers-are-not VI-Jon, LLC Expands Voluntary Worldwide Recall of All Flavors and Lots within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-worldwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate Vi-Jon, LLC is revising a previously reported list of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry Thu, 04 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-worldwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate Plastikon Healthcare Expands Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/plastikon-healthcare-expands-voluntary-nationwide-recall-milk-magnesia-oral-suspension-and-magnesium Plastikon Healthcare, LLC is issuing an update to the voluntary recall initiated on June 3, 2022. The recall has been expanded to include Lot 20076A of Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension. This lot was previously subject to a retai Thu, 04 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/plastikon-healthcare-expands-voluntary-nationwide-recall-milk-magnesia-oral-suspension-and-magnesium Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United States and Canada 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 Wed, 03 Aug 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 Distributor RFR, LLC, Voluntary Nationwide Recall of Sangter Energy Supplement Due to Presence of Undeclared Sildenafil http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/distributor-rfr-llc-voluntary-nationwide-recall-sangter-energy-supplement-due-presence-undeclared Miami, Florida, DISTRIBUTOR RFR, LLC. is voluntarily recalling lot #48656, Exp. 01/2025 of SANGTER Energy Supplement, 3000 mg, packaged in 7-count blister packs within a carton to the consumer level. FDA analysis has found the product to contain undeclared sildenafil. Sildenafil is a phosphodiestera Tue, 02 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/distributor-rfr-llc-voluntary-nationwide-recall-sangter-energy-supplement-due-presence-undeclared North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the 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 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 Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene 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 Covidien, LLC (Medtronic) Recalls Palindrome and Mahurkar Hemodialysis Catheters Due to Catheter Hub Defect 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 Vi-Jon, LLC Expands Voluntary Nationwide Recall of All Flavors and Lots Within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination 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 Ultra Supplement LLC Issues Voluntary Nationwide Recall of Sustango Due to the Presence of Undeclared Tadalafil 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 Baxter Healthcare Corporation Recalls Abacus Order Entry and Calculation Software for Risk of Medication Label Errors 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 UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication 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 UPDATE: FDA Updates Recommendations for the Use of Renuvion/J-Plasma Device for 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 FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication 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 UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication 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 Voluntary Recall of Certain Over-the-Counter Products 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