Reliability note

Titles and AI summaries are unofficial English monitoring aids, not legal advice or official translations. Each link opens the original Japanese official source, which remains authoritative.

PMDA Class I recall notice: Fresh Frozen Plasma-LR (Japanese Red Cross) 480

クラスI回収 該当回収品目 新鮮凍結血漿-LR「日赤」480

Published: 2026-08-03 · Source: Pharmaceuticals and Medical Devices Agency (PMDA) — Safety Updates · Stage: Government Announcement · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-08-06

View the original Japanese source More Healthcare / Pharmaceuticals updates Search all updates in the dashboard

AI summary

Generated by AI from the Japanese source metadata. It is an unofficial monitoring aid, not legal advice, and may contain errors. The area, stage, and impact labels are preliminary keyword-based triage labels. Confirm every point in the original Japanese source.

Summary

The Pharmaceuticals and Medical Devices Agency (PMDA) safety updates page lists a Class I recall entry for the product 'Fresh Frozen Plasma-LR (Japanese Red Cross) 480', dated 2026-08-03. This is a government-published recall notice; the metadata provided does not state the reason for the recall, affected lots, or required actions.

Business Impact

Healthcare providers, blood-product handlers, or distributors that deal with this product may need to check whether they are affected. Under PMDA's classification Class I generally denotes the highest-risk recall category, but the specific risk here is not stated in the provided metadata.

Recommended Action

Review the official PMDA recall page in Japanese to confirm the product details, scope, and any stated instructions.