FDA Device recall Z-1034-2022
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging
- FDA Device
- Class II
- ongoing
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging by Olympus, citing GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1034-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-18 |
| Published | 2022-05-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
Product
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Reason
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
Identifiers
| code_info | All serial numbers. GTIN: 04953170356322 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1034-2022%22
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