The FDA posts letters to health care providers about the safe use of medical devices.
Certain syringes and needles with needle safety devices manufactured by HAIOU may cause needles to detach in patients’ arms after injection or needle failure.
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.
Issues with BD Intraosseous needle kits and drivers may prevent treatments from being infused through the bone causing delays in care.
Haimen Shengbang is recalling Viral Transport Media Containers because they were distributed to U.S. customers without FDA authorization, clearance, or approval.
Vi-Jon, LLC is revising a previously reported list of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry
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
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
North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits because they are not authorized, cleared, or approved by the FDA.
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
Covidien, LLC (Medtronic) is recalling Palindrome and Mahurkar hemodialysis catheters due to catheter hub defect.
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
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
User changes in the Abacus order entry and calculation software labeling templates may cause incorrect information to appear on final medication labels.
Listing of Medical Device 2022 Safety Communications
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).
Renuvion/J-Plasma device can be used for additional aesthetic skin procedures
Renuvion/J-Plasma has not been cleared for Aesthetic Skin Procedures. FDA warns patients & health care providers of potential risks.
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
UV wands may cause injury to the skin, eyes, or both after a few seconds of use.