Olympus High Flow Insufflation Unit — Class I medical device recall Z-1352-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-02-25, distributed nationwide. Issue with software algorithm which may lead to overpressure events.
| Recall number | Z-1352-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2026-01-16 |
| Classified | 2026-02-18 |
| Reported by FDA | 2026-02-25 |
| Distributed | Nationwide (US) |
| Quantity | 18 units |
| Reason classes | software |
Product
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Reason for recall
Issue with software algorithm which may lead to overpressure events.
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-1352-2026. 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.