Green Silicone Seal for Accessories — Class II medical device recall Z-2140-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2025-07-30. Discrepancies between sterilization instructions in the Japanese language product package inserts and those pu
| Recall number | Z-2140-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2025-06-18 |
| Classified | 2025-07-21 |
| Reported by FDA | 2025-07-30 |
| Countries outside the US | JP |
| Quantity | 41 units |
| UPC / GTIN / UDI-DI | 00821925001190, 00821925038332 |
| Model numbers | CS-G7 |
Product
Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2140-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.