Regulatorische Updates

The Korean Food & Drug Administration tested 100 top‑selling hand sanitizers and found four failing the ingredient‑content standards, prompting sales suspension, recall and disposal.

Health Canada reports a limited number of Medtronic sterile passive spheres have variable reflective coating that could affect navigation system tracking.

Medtronic reports a variation in the reflective coating of certain sterile passive spheres, which could affect instrument detection and tracking during navigation procedures.

AlpBio’s marketing executive Nomi Seon was honored with the MFDS Director’s Award for his 25‑year contributions to the health functional food industry.

Domestic manufacturers have issued voluntary recalls for certain batches of diabetes treatments and anti‑emetic tablets after detecting contamination, potency failures and impurity exceedances.

Stryker discovered that some LifePak R-35 units may have printer and modem access port connectors not fully seated, potentially appearing flush or recessed.

Gore discovered some VIABAHN® devices were processed on equipment outside the validated range, potentially causing incorrect distal tip bonding.

Gore discovered some VIABAHN® devices were processed on equipment outside validated range, risking incorrect distal tip bonding.

Balt Extrusion is voluntarily recalling certain ANRYV connector lots after bacterial endotoxin test failures; no patient harm reported.

Balt Extrusion is voluntarily recalling specific ANRYV connector lots after non‑conforming bacterial endotoxin test results, affecting standalone connectors and those in selected kits; no patient harm reported.

The Korean Medical Association’s Korean Medicine Countermeasure Special Committee demands international‑standard oversight of external decoction rooms after a police‑investigated insurance fraud involving pre‑manufactured herbal prescriptions.