Elevated site urgencyFDA Class II

Olympus High Flow Insufflation Unit - UHI-4

Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

Agency
FDA Device
Recall date
Jun 16, 2026
Status
Ongoing
Company
Olympus Corporation of the Americas

1. What product was recalled?

Olympus High Flow Insufflation Unit - UHI-4

Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

Quantity: 3,087 units

Code or lot text: Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.

LOT
04953170467219. All Serial Numbers.
LOT
Model Number: UHI-4. UDI: 04953170324147
RECALL-NUMBER
Z-2776-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Device source

Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.