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 Intersurgical Inc. has issued a letter to affected customers recommending certain breathing systems be…
Family Farmstead Dairy Announces Recall of All Cheddar Cheese Products Because of Possible Health Risk
Summary Company Announcement Date: November 10, 2026 FDA Publish Date: November 10, 2026 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes. Company Name: Family Farmstead Dairy Brand Name: Brand Name(s) Family Farmstead Product Description: Product Description Raw Mild Cheddar; Raw Sharp Cheddar Company Announcement Worcester,…
Eugia US LLC (f/k/a Auro Medics Pharma LLC) Issues Voluntary Nationwide Recall of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) Due to Presence of Particulate Matter
Summary Company Announcement Date: November 06, 2026 FDA Publish Date: November 09, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter identified as a glass particle inside the vial Company Name: Eugia US LLC Brand Name: Brand Name(s) Product Description: Product Description Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose…
Fresh & Ready Foods LLC Recalls Fresh To You Brand Sausage, Egg & Cheese Biscuit Sandwich due to Possible Health Risk
Summary Company Announcement Date: November 08, 2026 FDA Publish Date: November 08, 2026 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes. Company Name: Fresh & Ready Foods LLC Brand Name: Brand Name(s) Fresh to You Product Description: Product Description Sausage, Egg & Cheese Biscuit Sandwich…
FDA Advises Consumers Not to Buy or Serve Once Upon a Farm Tractor Wheels Organic Toddler Soft-Baked Bars
AUDIENCE: Consumer, Patient, Health Care Professional, Pediatric ISSUE: The FDA has received several reports that describe toddlers (ages 1.5–2.5 years) suffering complete airway obstruction with the inability to breathe after consuming the product. When chewed, the product reportedly forms a dry, sticky mass that standard choking interventions — including back blows and the Heimlich maneuver…
Snack Right Super Foods, Inc. dba Brad’s Raw Chips Recalls Brad’s Crunchy Kale & Veggie Chips Due to Potential Thallium Contamination
Summary Company Announcement Date: November 02, 2026 FDA Publish Date: November 03, 2026 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Product may contain thallium. Company Name: Snack Right Super Foods dba Brad’s Raw Chips Brand Name: Brand Name(s) Product Description: Product Description Crunchy Kale and Veggie Chips Kale Company Announcement Coral…
Early Alert: Compact Medical Removes and Updates Use Instructions for ButterflyBVM Bag-Valve-Mask Resuscitators
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 Compact Medical has issued an “Urgent Medical Device Recall” notice to affected customers recommending…
Once Upon A Farm Recalls All Lots and Varieties of Tractor Wheels Organic Toddler Soft-Baked Bars Due to Potential Choking Hazard
Summary Company Announcement Date: October 30, 2026 FDA Publish Date: November 02, 2026 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential choking hazard Company Name: Once Upon a Farm Brand Name: Brand Name(s) Once Upon a Farm Product Description: Product Description Tractor Wheels Organic Toddler Soft-Baked Bars (all lots and varieties)…
Early Alert: B. Braun Medical Inc. Removes Streamline Bloodline Set for Dialog+
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 B. Braun Medical Inc. has issued a letter to affected customers recommending certain Hemodialysis…
Platelet Factor 4 (PF4) Radioimmunoassay Recall: Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG(PF4-H)
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 Instrumentation Laboratories (Werfen) has issued letters to affected customers recommending…