Olympus Ultrasound Endoscope — Class II medical device recall Z-0503-2021
Terminated recall by Olympus Corporation of the Americas, reported 2020-12-09, distributed nationwide. A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for
| Recall number | Z-0503-2021 |
|---|---|
| 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 | 2020-10-16 |
| Classified | 2020-11-27 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2022-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 31 devices |
| Model numbers | GF-UMQ130 |
Product
Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.
Reason for recall
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
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-0503-2021. 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.