Date Issued: June 3, 2026 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers of the elevated long-term risk of device failure, higher-than-expected risk of revision surgery, and risk of polyethylene fracture (plastic breakage) observed in the Hintermann Series H3 Total Ankle Replacement (TAR) System (also referred to as…
Early Alert: Catheter Introducer Kit Issue from Abiomed
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 Abiomed has issued a letter to affected customers recommending all 14Fr Low Profile Introducer…
Champion Foods Recalls Some Batches of Motor City Pizza Co. 5 Cheese Bread Because of Possible Health Risk
Summary Company Announcement Date: May 29, 2026 FDA Publish Date: June 01, 2026 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Possible Salmonella Contamination Company Name: Champion Foods LLC Brand Name: Brand Name(s) Motor City Pizza Co. Product Description: Product Description Motor City Pizza Co. 5 Cheese Bread Single and…
Dialysis Catheter Kit Recall: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers
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…
Dexcom Uncovers Theft of Scrapped Product, Notifies Potentially Impacted Users
Summary Company Announcement Date: May 26, 2026 FDA Publish Date: May 29, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Sensors identified as scrap were diverted and sold by third-party Company Name: Dexcom, Inc. Brand Name: Brand Name(s) Product Description: Product Description Continuous Glucose Monitoring System Company Announcement Through ongoing quality and…
Pediatric Care Bed Correction: KayserBetten Issues Correction for KayserBett IDA Beds
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 you continue to use it without correction. Affected Product The FDA is aware that KayserBetten has issued a letter to affected customers recommending…
Manifold Recall: Medline Removes Namic Star Off Handle Manifolds
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 Medline has issued a letter to affected customers recommending certain…
DE DIOS’S ICE POPS II LLC Issues Allergy Alert on Undeclared Milk, Pecans, Pistachio, Yellow #5, and Red #40 in Popsicles
Summary Company Announcement Date: May 27, 2026 FDA Publish Date: May 27, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description May Contain undeclared milk, pecans, pistachios, yellow #5 and red #40 Company Name: De Dios’s Ice Pops II LLC Brand Name: Brand Name(s) D’Dioses Product Description: Product Description Fruit popsicles…
Early Alert: IV Tubing Set Issue from ICU 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. Affected Product The FDA is aware that ICU Medical has issued a customer communication recommending certain IV tubing sets be removed…
Bazzini Voluntarily Recalls Certain Lots of SkinnyDipped® Dark Chocolate Coconut Almond Bites Due to Undeclared Peanut Allergen
Summary Company Announcement Date: May 27, 2026 FDA Publish Date: May 27, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description May Contain undeclared peanuts Company Name: Bazzini, LLC Brand Name: Brand Name(s) SkinnyDipped Product Description: Product Description Dark Chocolate Coconut Almond Bites Company Announcement Bazzini, LLC, of Allentown, PA, a…