Olympus Corporation of the Americas medical device recall: Olympus High Flow Insufflation Unit. Model Number: UHI. Used for…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98243
- Recall initiated
- Jan 16, 2026
- Classified by FDA
- Feb 18, 2026
- Posted in Enforcement Report
- Feb 25, 2026
- Recalling firm
- Olympus Corporation of the Americas
- Firm location
- Center Valley, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Issue with software algorithm which may lead to overpressure events.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jan 16, 2026. FDA classified it 33 days later, on Feb 18, 2026. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: Nationwide distribution Olympus Corporation of the Americas has 145 recalls in our records.
Recalled products (3)
Z-1352-2026 Class I Ongoing
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.
Codes / lots: Model Number: UHI; UDI-DI: N/A; All Serial Numbers
Quantity: 18 units
Z-1353-2026 Class I Ongoing
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.
Codes / lots: Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers
Quantity: 744 units
Z-1354-2026 Class I Ongoing
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.
Codes / lots: Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers.
Quantity: 485 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98243
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.