규제 업데이트

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.

Olympus advises immediate discontinuation of BiCOAG Hemostasis Probe due to possible adhesive shortage causing ceramic tip detachment.

Samchundang Pharmaceutical was ordered to halt production after the MFDS found irregularities in a potency test and a failure to submit a recall plan for its contracted Lefurozin syrup.

The Ministry of Food and Drug Safety has recalled specific batches of Daewoong Pharmaceutical’s ezetimibe/rosuvastatin tablets and products from YS Life Science due to packaging label discrepancies.

Health Canada has issued a retail recall of JAMP Temozolomide 140 mg capsules (lot RLTS0225A) because the active ingredient temozolomide is out of specification.

Health Canada alerts that Carestation 850 and 850C anesthesia systems may shut down unexpectedly if AC mains power is disconnected or lost.

Health Canada alerts that Carestation 850 and 850C anesthesia systems may shut down unexpectedly when AC mains power is lost.

Gentherm Medical reports that 0.53% of Blanketrol RII 115V and RIII 115V devices have overheated circuit boards, potentially causing shutdowns. No injuries reported; users may continue use with caution.

The Korean MFDS has ordered a retailer‑initiated recall of Il Dong Pharmaceutical’s Consenvita Premium 800 tablets (batch RWC009, RWC010) because of missing labeling information and packaging errors.

Amgen voluntarily recalls about 1 million bottles of its heart‑failure drug Corlanor in the US after potential foreign particles were identified.

The FDA has initiated a recall because the product lacks assurance of sterility, raising safety concerns.

Abiomed has issued a voluntary recall of all Automated Impella Controllers in Canada due to purge flag component failures that can affect device performance.