Olympus JF-140F duodenoscopes — Class II medical device recall Z-2269-2018
Terminated recall by Olympus Corporation of the Americas, reported 2018-06-27, distributed nationwide. Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of
| Recall number | Z-2269-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2018-05-11 |
| Classified | 2018-06-21 |
| Reported by FDA | 2018-06-27 |
| Terminated | 2020-05-05 |
| Distributed | Nationwide (US) |
| Quantity | 994 |
| Model numbers | JF-140F |
Product
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Reason for recall
Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.
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-2269-2018. 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.