2022 Letters to Health Care Providers
The FDA posts letters to health care providers about the safe use of medical devices.
FDA MedWatch
Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by Haiou – Letter to Health Care Providers
Certain syringes and needles with needle safety devices manufactured by HAIOU may cause needles to detach in patients’ arms after injection or needle failure.
At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of 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.
Becton Dickinson Recalls Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers for Issues That May Cause Delayed Treatment Delivery
Issues with BD Intraosseous needle kits and drivers may prevent treatments from being infused through the bone causing delays in care.
Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA
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 Expands Voluntary Worldwide Recall of All Flavors and Lots within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination
Vi-Jon, LLC is revising a previously reported list of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry
Plastikon Healthcare Expands Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination
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
Distributor RFR, LLC, Voluntary Nationwide Recall of Sangter Energy Supplement Due to Presence of Undeclared Sildenafil
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 That Are Not Authorized, Cleared, or Approved by the FDA
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 Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene
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) Recalls Palindrome and Mahurkar Hemodialysis Catheters Due to Catheter Hub Defect
Covidien, LLC (Medtronic) is recalling Palindrome and Mahurkar hemodialysis catheters due to catheter hub defect.
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
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
Ultra Supplement LLC Issues Voluntary Nationwide Recall of Sustango Due to the Presence of 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
Baxter Healthcare Corporation Recalls Abacus Order Entry and Calculation Software for Risk of Medication Label Errors
User changes in the Abacus order entry and calculation software labeling templates may cause incorrect information to appear on final medication labels.
2022 Safety Communications
Listing of Medical Device 2022 Safety Communications
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
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).
UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication
Renuvion/J-Plasma device can be used for additional aesthetic skin procedures
FDA Warns Against Use of Renuvion/J-Plasma Device for 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.
Voluntary Recall of Certain Over-the-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
Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety Communication
UV wands may cause injury to the skin, eyes, or both after a few seconds of use.