Z-2139-2025 Class II Ongoing
FDA device recall Z-2139-2025 was initiated by Olympus Corporation of the Americas on June 18, 2025 and is designated Class II. 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). The recall status is ongoing. Affected quantity: 19 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 30, 2025
- Initiation Date
- June 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
Product Description
Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.
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).
Distribution Pattern
International distribution to the country of Japan.
Code Information
Model Number: CS-B612. UDI-DI: 00821925038318, 00821925001176. All lot numbers