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FDA device recall Z-2142-2025 · posted 2025-07-21 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
- Action taken
- Olympus notified consignees on about 06/18/2025 via letter. Consignees were instructed to review the notification and arrange for the return of all affected units on hand, ensure all affected personnel are aware, and notify customers if the affected units were further distributed. Olympus also requested that consignees complete and return the response form acknowledging receipt of the notification.
- Root cause
- Packaging change control
- Status
- Open, Classified
- Product code
- KQT
- Quantity affected
- 1 unit
- Distribution
- International distribution to the country of Japan.
- Date initiated
- 2025-06-18
- Date posted
- 2025-07-21
- Location
- Center Valley, PA
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