This communication is a medical device early alert. The FDA has become aware 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 AirLife has issued a letter to affected customers recommending certain Broselow…
Olympus Expands Voluntary Recall for ViziShot 2 FLEX (19G) EBUS -TBNA Needles
Summary Company Announcement Date: January 16, 2026 FDA Publish Date: January 16, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device & Drug Safety – Defect Company Name: Olympus Corporation Brand Name: Brand Name(s) Product Description: Product Description ViziShot 2 FLEX (19G) EBUS -TBNA needles Company Announcement CENTER VALLEY, Pa., (January 16,…
Early Alert: Stent and Electrocautery-Enhanced Delivery System Issue from Boston Scientific
This communication is a medical device early alert. The FDA has become aware 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 Boston Scientific has issued a letter to affected customers recommending certain…
Anesthesia Kit Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit Kits
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…
Abbott Initiates Medical Device Correction for Certain FreeStyle Libre® 3 and FreeStyle Libre 3 Plus Sensors in the U.S.
Summary Company Announcement Date: November 24, 2025 FDA Publish Date: January 15, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Internal testing determined that some sensors may provide incorrect low glucose readings. Company Name: Abbott Brand Name: Brand Name(s) FreeStyle Libre Product Description: Product Description FreeStyle Libre 3 and 3 Plus Glucose…
Early Alert: Dialysis Tubing Set Issue from Vantive
The FDA has become aware 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 Vantive has issued a letter informing affected customers that Prismaflex Control Units have updated use instructions. Affected devices: Device…
Infusion Pump Recall: Fresenius Kabi Removes Ivenix Large Volume Pumps
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 Fresenius Kabi has issued a letter to affected customers recommending…
Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Bravo CF Capsule Delivery Devices
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 Medtronic and their subsidiary Given Imaging Inc. have issued two…
Organ Recovery Pack Correction: AVID Medical Issues Correction for Medical Convenience and Organ Recovery Kits
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. Affected Product The FDA is aware that AVID Medical has issued…
Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam
Summary Company Announcement Date: January 07, 2026 FDA Publish Date: January 09, 2026 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Unapproved new drug found to contain undeclared meloxicam Company Name: Anthony Trinh, 123Herbals LLC Brand Name: Brand Name(s) Product Description: Product Description Dietary supplement capsules marketed for relief of joint and body…