Prismaflex Set deaeration chambers may dislodge from the Prismaflex Control Unit during use.
Prismaflex Set deaeration chambers may dislodge from the Prismaflex Control Unit during use.
Integra LifeSciences is removing certain lots of Microsensor and Cerelink ICP Kits with potential corrosion stains on the included Tuohy Needle.
ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (NASDAQ: PODD) (“Insulet” or the “Company”) today initiated a voluntary Medical Device Correction for specific lots of Omnipod® 5 Pods after identifying a manufacturing issue through its ongoing product monitoring. This action applies to specific i...
Erbe Cryoprobes may rupture during activation, leading to potential hearing loss, tinnitus, injury, or burns...
Integra is removing certain Wound and Burn Dressing products that may have breached sterile barriers.
Certain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis.
Certain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis...
These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices.
Fresenius Kabi is correcting Ivenix LVP software due to anomalies that could cause serious patient harm or death...
Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stops...
Boston Scientific is removing certain stents and delivery systems due to issues with deployment and expansion.
Olympus is removing certain High Flow Insufflation Unit models due to software issues that may lead to overpressure events.
Trividia recommends that device users who receive an E-5 error code and are experiencing symptoms of high glucose should seek medical care immediately...
Medline updates use instructions for Electronic Homecare Beds due to risk of electrical fires and entrapment.
AirLife is removing Broselow Rainbow Tapes due to incorrectly printed medication dosing information.
FT. LAUDERDALE, FL) – February 6, 2026 – Trividia Health, Inc., announced today that it is initiating a labeling correction which requires a modification of the Owner’s Booklets/System Instructions for Use for all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monit...
MedTech/CERENOVUS is removing CEREPAK Detachable Coil Systems due to a higher than expected failure to detach rate...
Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may incorrect or lower than actual glucose readings...
FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.
The differential pressure sensor in certain Impella devices may malfunction and cause sensor values to drift.