Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
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Actualizaciones regulatorias
25 sept 2026•1 min de lectura
Canada Recalls PERMA-HAND Silk Suture for Unapproved Tubing Fluid
Health Canada has recalled Ethicon's PERMA-HAND™ Silk Suture after discovering an unapproved alcohol‑based tubing fluid in its primary packaging.
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
Health Canada Recall: PERMA‑HAND™ Silk Suture Contaminated with Alcohol‑Based Tubing Fluid
Ethicon recalls PERMA‑HAND™ Silk Suture after discovering an alcohol‑based tubing fluid was used in manufacturing.
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
Stryker alerts premature battery drain in certain devices
Stryker reports some devices may suffer early battery loss, leading to power issues and coil detachment failure.
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
Stryker devices may experience premature battery drain, affecting operation
Stryker reports that some devices can suffer premature battery drain, leading to power failures, weak indicators, or coil detachment issues.
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
Medtronic Reports 15 Complaints on Incompatible Component Health Canada
Medtronic logged 15 complaints about incompatible leads or extensions causing surgical delays, but found no performance issues.
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
Medtronic Reports 15 Complaints Over Incompatible Component Selection
Medtronic logged 15 complaints from Jan 2020 to Aug 2026 involving incompatible leads or extensions, causing surgery delays or replacements, but found no device performance issues.
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
Cook Medical Alerts: Female Luer Lock Adapter May Be Misaligned in Certain Device Lots
Cook Medical reports that certain device lots may have a misaligned female luer lock adapter due to manufacturing errors.
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
Cook Medical alerts on potential manufacturing defect in cystoscopic injection needle
Cook Medical reports that certain cystoscopic injection needle lots may have a misaligned female luer lock adapter.
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
Health Canada Issues Alert on 3930M Transvenous DF4 Cardiac Lead Adhesive Issue
Health Canada alerts that the 3930M transvenous DF4 cardiac lead may suffer driveshaft separation due to insufficient adhesive bonding, potentially leading to lead fracture.
Actualizaciones regulatorias
23 sept 2026•1 min de lectura
MHRA Field Safety Notices Issued 14‑18 September 2026
MHRA published a series of field safety notices between 14‑18 Sep 2026 covering cardiac occluders, circulatory assist catheters, orthopedic instruments, endoscopic needles, imaging systems and diagnostic software.
Actualizaciones regulatorias
21 sept 2026•1 min de lectura
South Korea Expands Insurance Support for Insulin Pumps and CGMs to Severe Type 2 Diabetes
The Ministry of Health and Welfare will extend coverage of insulin pumps and continuous glucose monitors to severe type 2 diabetes patients with pancreatic dysfunction starting December.
Actualizaciones regulatorias
18 sept 2026•1 min de lectura
Health Canada Warns of Counterfeit Soprano Laser Hair Removal Devices
Health Canada alerts that counterfeit Soprano laser hair removal machines, made by Beijing Perfectlaser, are being sold to Canadian clinics, posing health risks.