FDAClass II · Medical device · Recall Z-2776-2026 · Recalled July 29, 2026

Olympus High Flow Insufflation Unit - UHI-4 recall — Olympus Corporation of the Americas

Agency report date: July 29, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Olympus High Flow Insufflation Unit - UHI-4
Company / brand: Olympus of the Americas
Lot / serial / date codes: Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, El Salvador, Germany, Honduras, Hong Kong, India, Ireland, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Paraguay, Peru, Russia, Singapore, Sri Lanka, Taiwan, Thailand, United Kingdom, Uruguay, Vietnam.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Olympus High Flow Insufflation Unit - UHI-4

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2776-2026
Brand: Olympus of the Americas
Classification: Class II
Units affected: 3,087 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Olympus High Flow Insufflation Unit - UHI-4

Companies & origin

Recalling firm location: Center Valley, PA, United States
Firm address: 3500 Corporate Pkwy, N/A, 18034-8229

Identifying details (verbatim from the notice)

Product codes / lots: Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, El Salvador, Germany, Honduras, Hong Kong, India, Ireland, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Paraguay, Peru, Russia, Singapore, Sri Lanka, Taiwan, Thailand, United Kingdom, Uruguay, Vietnam.
Firm notified the public via: Letter
FDA event ID: 99109
Recall initiated: June 16, 2026
FDA classified: July 22, 2026
FDA report date: July 29, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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