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 B. Braun Medical, Inc. has issued a letter to affected…
Khong Guan Corporation Issues Expanded Recall of Glutinous Rice Balls With Black Sesame Filling to Include Black & White Glutinous Rice Balls With Black Sesame Filling Due to Undeclared Peanuts
Summary Company Announcement Date: July 15, 2026 FDA Publish Date: July 15, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description May Contain Undeclared Peanuts Company Name: Khong Guan Corporation Brand Name: Brand Name(s) Khong Guan Corporation Product Description: Product Description Glutinous Rice Balls with Black Sesame Filling and Black &…
Early Alert: Ventilator Issue from Resmed
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 Figure 1. Astral 150. The FDA is aware that Resmed has issued a letter to affected customers recommending that…
Fayus Inc., dba Yusol International Foods Recalls OLA-OLA POUNDED YAM Due to Undeclared Milk Allergen
Summary Company Announcement Date: July 06, 2026 FDA Publish Date: July 07, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description May contain undeclared milk in the form of sodium caseinate Company Name: Fayus, Inc. Brand Name: Brand Name(s) Product Description: Product Description Pounded Yam Company Announcement Fayus Inc., doing business…
Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing Devices
The affected products and recommendations for what to do with the devices below have not changed. This recall involves correcting 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…
Khong Guan Corporation Issues Recall of Glutinous Rice Balls With Black Sesame Filling Due to Undeclared Peanuts
Summary Company Announcement Date: July 13, 2026 FDA Publish Date: July 13, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description May Contain Undeclared Peanuts Company Name: Khong Guan Corporation Brand Name: Brand Name(s) Khong Guan Corporation Product Description: Product Description Glutinous Rice Balls with Black Sesame Filling Company Announcement Khong…
Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)
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 Medtronic has issued a letter to affected customers recommending certain…
Early Alert: Convenience Kits Issue from Medline
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 Medline has issued a letter to affected customers recommending certain convenience kits be…
Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps
This recall involves correcting 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 correction. Affected Product The FDA is aware that Fresenius Kabi…
Faysu Inc., dba Yusol International Foods Recalls OLA-OLA POUNDED YAM Due to Undeclared Milk Allergen
Summary Company Announcement Date: July 06, 2026 FDA Publish Date: July 07, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description May contain undeclared milk in the form of sodium caseinate Company Name: Fayus, Inc. Brand Name: Brand Name(s) Product Description: Product Description Pounded Yam Company Announcement Fayus Inc., doing business…