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…
Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
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…
Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
The affected products and recommendations for what to do with the devices below have not changed. This recall involves correcting certain 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…
Frutas y Hortalizas del Sur S.A. Initiates Recall of Frozen GreenWise Organic IQF Blueberries Due to Potential E. coli O145 Contamination
Summary Company Announcement Date: July 03, 2026 FDA Publish Date: July 06, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Possible E. Coli Contamination Company Name: Frutas y Hortalizas del Sur S.A. Brand Name: Brand Name(s) Product Description: Product Description Organic IQF Frozen Blueberries 10 oz Company Announcement July…
Insulin Pump Recall: Insulet Removes Omnipod Pods
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. The affected products and recommendations for what to do with the devices below have not changed. Affected…
Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
The affected products and recommendations for what to do with the devices below have not changed. This recall involves updating instructions for using certain 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…
Voluntary Recall of Two Lots of PEDIGREE® Can High Protein Chopped Chicken & Duck Flavor Wet Dog Food Due to Potential Fraudulent Distribution of Product Which May Contain Foreign Material
Summary Company Announcement Date: July 02, 2026 FDA Publish Date: July 02, 2026 Product Type: Animal & VeterinaryFood & Beverages Pet Food Reason for Announcement: Recall Reason Description Potential foreign plastic contamination Company Name: Mars Petcare US, Inc. Brand Name: Brand Name(s) Product Description: Product Description High Protein Chopped Chicken & Duck Flavor Wet Dog…
Gellert Global Group Issues Allergy Alert on Undeclared Tuna (Fish) in Aldi Brand Fusia Asian Inspirations Kimchi and Tofu Kimbap
Summary Company Announcement Date: July 02, 2026 FDA Publish Date: July 02, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Product contains undeclared fish (tuna) Company Name: Gellert Global Group Brand Name: Brand Name(s) Product Description: Product Description Kimchi & Tofu Kimbap Company Announcement Gellert Global Group of Elizabeth, NJ…