CLASS I ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report
Olympus High Flow Insufflation Unit recalled
Olympus Corporation of the Americas is recalling Olympus High Flow Insufflation Unit, distributed nationwide in the US. The recall was initiated on 16 Jan 2026 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1353-2026
- FDA event ID
- 98243
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 16 Jan 2026
- FDA classified
- 18 Feb 2026
- Reported
- 25 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 16 Jan 2026 | Recall initiated by company | |
| 18 Feb 2026 | Classified by FDA | +33 days |
| 25 Feb 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Issue with software algorithm which may lead to overpressure events.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Nationwide distribution
Questions about this recall
Why was it recalled?
Issue with software algorithm which may lead to overpressure events.
Which lots are affected?
Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers
Where was it sold?
Nationwide distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98243This product is part of a recall event; the main page for the event is Olympus High Flow Insufflation Unit recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Olympus High Flow Insufflation Unit recalled | Olympus Corporation of the Americas | Device Malfunction | Nationwide | |
| CLASS I | Olympus High Flow Insufflation Unit recalled | Olympus Corporation of the Americas | Device Malfunction | Nationwide |
More recalls from Olympus Corporation of the Americas
All 423| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Olympus M3 Gold Autoclavable Lateral Telescope recalled | Olympus Corporation of the Americas | Sterility | PA |
| Device | CLASS II | Olympus Tripp-Lite P580-025 25ft DisplayPort Cable recalled | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Olympus M3 Gold Autoclavable Foroblique Telescope recalled | Olympus Corporation of the Americas | Sterility | PA |
| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Fixed Pin Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Coaxial Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
Other Surgical Instruments recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |