MedWatch Safety Alerts

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

2022 Letters to Health Care Providers

The FDA posts letters to health care providers about the safe use of medical devices

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

FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall

Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

This update provides additional information on the recall and recommendations for people who use repaired and replaced devices

2022 Medical Device Recalls

List of Medical Device recalls in 2022

2022 Safety Communications

Listing of Medical Device 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

Issues with BD Intraosseous needle kits and drivers may prevent treatments from being infused through the bone causing delays in care

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

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

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

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

Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United States and Canada

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

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

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

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

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

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

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

General Information