# FDA recall Z-2139-2025

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2025-06-18.

## Product

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

International distribution to the country of Japan.

## Key facts

- **Recall number:** Z-2139-2025
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-18
- **Report date:** 2025-07-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2139-2025

## Citation

> AI Analytics. FDA recall Z-2139-2025. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-2139-2025. Source: US FDA. Licensed CC0.

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