FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product

CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment durin

Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers.

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices; asks for reports of injuries related these devices

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller

(FT. LAUDERDALE, FL) –October 7, 2025 – Trividia Health, Inc., announced today that it is initiating a voluntary recall of a limited number of TRUE METRIX® Self-Monitoring Blood glucose meters co-branded under the Good Neighbor Pharmacy® brand and distributed in the United States.

What is a Medical Device Recall?

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

Early Alerts minimize time between FDA’s initial awareness of a potentially high-risk medical device removal or correction and FDA’s public communication

.This page includes a list of various resources offered by the FDA regarding recalls and alerts for medical devices
 

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

Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.

3M is correcting their Ranger Blood/Fluid Warming System due to incomplete temperature and flow rate specifications on the label.

3M is correcting their Ranger Blood/Fluid Warming System due to incomplete temperature and flow rate specifications on the label.

Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues

CENTER VALLEY, Pa., (September 19, 2025) — Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) manufactured prior to May 12, 2025, after receiving reports of device components detaching during procedures

Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues