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 Hamilton Medical has issued a letter to affected customers recommending certain coaxial breathing circuit…
Early Alert: Infant Resuscitation System Issue from GE HealthCare
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 GE HealthCare has issued a letter to affected customers recommending Infant Resuscitation Systems and…
Haleon Issues Voluntary Nationwide Recall of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct.
Summary Company Announcement Date: June 04, 2026 FDA Publish Date: June 04, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential chemical contamination Company Name: Haleon Brand Name: Brand Name(s) Product Description: Product Description Gass-X Extra Strength Softgels 120 and 72ct Company Announcement WARREN, N.J., June 4, 2026 — Haleon (NYSE: HLN) is…
Anesthesia Kit Correction: Becton Dickinson Issues Correction for BD Spinal Trays Containing Bupivacaine Ampules
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 Bupivacaine Ampule Example kit with Bupivacaine ampule…
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…
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…