Ultrasonic Gastrovideoscope — Class II medical device recall Z-1034-2022
Ongoing recall by Olympus Corporation of the Americas, reported 2022-05-11, distributed nationwide. GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection co
| Recall number | Z-1034-2022 |
|---|---|
| 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 | 2022-03-18 |
| Classified | 2022-05-05 |
| Reported by FDA | 2022-05-11 |
| Distributed | Nationwide (US) |
| Quantity | 731 units |
| UPC / GTIN / UDI-DI | 04953170356322 |
Product
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Reason for recall
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
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-1034-2022. 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.