UPDATE: Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication

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…

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…

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…

Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® Pods in the U.S. and Affected International Markets

Summary Company Announcement Date: May 26, 2026 FDA Publish Date: May 26, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Manufacturing issue that could result in under delivery of insulin Company Name: Insulet Corporation, Inc. Brand Name: Brand Name(s) Product Description: Product Description Device intended for the subcutaneous delivery of insulin into…

Ventilator Recall: React Health Removes VOCSN V+Pro Ventilators

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 Ventec, doing business as React Health, has issued a…