MedWatch Safety Alerts

Early Alert: Wound and Burn Dressing Issue from Integra LifeSciences

Integra is removing all MediHoney Wound and Burn products and certain lots of CVS Wound Gel that may have breached sterile barriers

Early Alert: Insufflation Unit Issue from Olympus

Olympus is removing certain High Flow Insufflation Unit models due to software issues that may lead to overpressure events

Early Alert: Stent and Electrocautery-Enhanced Delivery System Issue from Boston Scientific

Boston Scientific is removing certain stents and delivery systems due to issues with deployment and expansion

Anesthesia Kit Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit Kits

Medline is removing certain anesthesia circuit kits due to cracks and leaks in the tubing

Olympus Expands Voluntary Recall for ViziShot 2 FLEX (19G) EBUS -TBNA Needles

CENTER VALLEY, Pa., (January 16, 2026) — Olympus Corporation has announced the expansion of a previous global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA

Anesthetic Vaporizer Recall: Draeger Removes Vapor 2000 and Vapor 3000 Vaporizers

Draeger is removing certain Vapor 2000 and Vapor 3000 Vaporizers due to impurities found within a component

Early Alert: Broselow Rainbow Tape Issue from AirLife

AirLife is removing Broselow Rainbow Tapes due to incorrectly printed medication dosing information

Abbott Initiates Medical Device Correction for Certain FreeStyle Libre® 3 and FreeStyle Libre 3 Plus Sensors in the U.S.

ABBOTT PARK, Ill., Nov. 24, 2025 — Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after

Early Alert: Dialysis Tubing Set Issue from Vantive

Prismaflex Set deaeration chambers may dislodge from the Prismaflex Control Unit during use

Organ Recovery Pack Correction: AVID Medical Issues Correction for Medical Convenience and Organ Recovery Kits

AVID is removing bags from Organ Recovery and Medical Convenience Kits due to the bags being made of non-medical grade Poly and lacking intact seals

Modern Warrior Recalls “Modern Warrior Ready” Dietary Supplement Due to Undeclared 1,4-DMAA and Aniracetam, as Well as Tianeptine, Which has Not Been Approved for Supplement Use by the FDA.

[Phoenix, Arizona] – [12/22/25] – Modern Warrior is voluntarily recalling all lots of Modern Warrior Ready, a dietary supplement sold directly to consumers, after regulatory

Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam

Rosemead, CA, ANTHONY TRINH, 123herbals LLC is voluntarily recalling all lots of Silintan capsules to the consumer level. FDA analysis has found the product to be tainted with

Intravascular PICC Catheter Recall: Bard Removes PowerPICC Intravascular Catheters

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Infusion Pump Software Recall: Baxter Removes Sigma Spectrum Infusion System Platforms

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Diagnostic Intravascular Catheter Recall: Conavi Removes Novasight Hybrid Catheters

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Aspiration System Correction: Calyxo Updates Use Instructions for CVAC Aspiration Systems

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Bravo CF Capsule Delivery Devices

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Infusion Pump Recall: Fresenius Kabi Removes Ivenix Large Volume Pumps

Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications

Custom Surgical Pack Recall: Alcon Removes Custom Pak Ophthalmic Procedure Packs

Alcon recalls Custom Pak Ophthalmic Procedure Packs due to incomplete seals that may compromise sterility. Check lot numbers, recall instructions

Intravascular Administration Set Recall: ICU Medical Removes IV Gravity Burette Set

ICU Medical removes IV Gravity Burette Set due to the burette component missing an internal shut-off valve intended to stop fluid flow