Olympus UHI-3 Insufflation Unit Recall: Software Overpressure Risk
Olymp: Olympus UHI-3 insufflation units may overpressurize abdominal cavities due to software issues. Affected units include all serial numbers with model UHI-3. Contact Olympus for remedy.
Use caution until it’s fixed
Issue with software algorithm which may lead to overpressure events.
Contact the company
What happened, in plain English
Olympus recalls all UHI-3 High Flow Insufflation Units due to a software issue that could cause overpressure in the abdominal cavity during medical procedures. This risk may lead to serious injury if the device malfunctions during surgery. Read more at govinfonow.com/recall/50147-olympus-uhi-3-insufflation-unit-recall-software-overpressure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/50147-olympus-uhi-3-insufflation-unit-recall-software-overpressure-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1354-2026
Cite this page
“Olympus UHI-3 Insufflation Unit Recall: Software Overpressure Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50147-olympus-uhi-3-insufflation-unit-recall-software-overpressure-risk. Based on FDA recall #Z-1354-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1354-2026%22&limit=1).
Why it’s dangerous
The software algorithm in the UHI-3 unit may malfunction, causing excessive pressure in the abdominal cavity during surgery. This overpressure could potentially lead to serious injury or complications for patients.
Who’s affected
Medical professionals using the Olympus UHI-3 units for laparoscopic surgery are most at risk. Patients undergoing procedures with this device could also be affected if the overpressure occurs.
How to tell if you have this one
Check for the model number UHI-3 on the device. All units with serial numbers listed in the recall are affected. The device is used for laparoscopic surgery procedures.
- Brand
Olympus- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
Nationwide distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1352-2026 | 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.; Model Number: UHI; UDI-DI: N/A; All Serial Numbers | 18 units |
| Z-1353-2026 | Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.; Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers | 744 units |
| Z-1354-2026 | Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.; Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers. | 485 units |
What to do — step by step
Check Device Model
Look for the model number UHI-3 on the device label.
Contact Olympus
Reach out to Olympus Corporation of the Americas for specific remedy instructions.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1354-2026 (January 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1354-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.