CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Medical Action Industries has issued a letter to affected customers recommending certain angiographic syringes…
Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted TMJ Implants
This recall involves correcting devices where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product The FDA is aware that Stryker has issued letters to affected customers recommending certain TMJ Unilateral…
Dialysis Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product The FDA is aware that Merit Medical has issued a letter to affected customers…
Liquid Blenz Corp. Recalls Product Due to Possible Health Risk
Summary Company Announcement Date: April 06, 2026 FDA Publish Date: April 14, 2026 Product Type: Food & Beverages Carbonated Soft Drinks Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness -Botulism Company Name: Liquid Blenz Corp Brand Name: Brand Name(s) Good Brain Tonic Product Description: Product Description Good Brain Tonic 16 oz &…
Early Alert: Sizing Catheter Issue from Cook Medical
Affected Product The FDA is aware that Cook Medical has issued a letter to affected customers recommending certain sizing catheters be removed from where they are used or sold. The affected devices are: Centimeter Sizing Catheters Aurous Centimeter Sizing Catheters Beacon Tip Centimeter Sizing Catheters The full list of affected product lots can be found here. What…
Early Alert: Convenience Kit Issue from AVID Medical
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. The FDA is aware that AVID Medical has issued an Urgent Medical Device Recall Notification to affected customers recommending certain…
Ventilator Correction: Baxter Updates Use Instructions for Volara Single-Patient Use Circuits
This recall involves updating instructions for using all devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. Affected Product…
Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination
Summary Company Announcement Date: April 08, 2026 FDA Publish Date: April 08, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Products were found to contain Lysinibacillus fusiformis, an environmental organism Company Name: Blaine Labs, Inc. Brand Name: Brand Name(s) Revitaderm, Tridergel Product Description: Product Description Antiseptic wound care gel bottles and tubes Company…
Nalpac Issues Voluntary Nationwide Recall of DTF Sexual Chocolate Due to the Presence of the Pharmaceutical Ingredient’s Sildenafil and Tadalafil
Summary Company Announcement Date: April 06, 2026 FDA Publish Date: April 07, 2026 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Tadalafil Company Name: Nalpac Brand Name: Brand Name(s) DTF Sexual Chocolate Product Description: Product Description Company Announcement FOR IMMEDIATE RELEASE – Date – Ferndale, Michigan. Nalpac is voluntarily…
Purge Cassette Recall: Abiomed Removes Impella Heart Pump Purge Cassettes
The affected products and recommendations for what to do with the devices below have not changed. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected…