Olympus Recalls High Flow Insufflation Units Due to Overpressure Risk
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Olympus Corporation of the Americas is recalling 485 UHI-3 High Flow Insufflation Units because a software defect may cause dangerous overpressure events during laparoscopic procedures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevice.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of its High Flow Insufflation Units, specifically Model UHI-3. The recall was triggered by an issue with the software algorithm which may lead to overpressure events while the device is in use.
Which Products Are Affected
The recall involves the following medical device:
- Product Name: Olympus High Flow Insufflation Unit
- Model Number: UHI-3
- UDI-DI: 04953170140280, 04953170140297
- Serial Numbers: All serial numbers are included in this recall
- Quantity: 485 units
- Distribution: Nationwide distribution across the United States
- Recall Number: Z-1354-2026
These units are designed for insufflation of the abdominal cavity, as well as automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment.
What You Should Do
Olympus initiated the recall process by sending notification letters to affected customers on January 16, 2026. Healthcare facilities and providers using the UHI-3 model should follow the instructions provided in the firm's correspondence. For further inquiries, the recalling firm is located at 3500 Corporate Pkwy, Center Valley, PA 18034.
Why This Matters
This is a Class I recall, the most serious classification, because the software defect can lead to overpressure in the abdominal cavity, posing a significant risk of injury or health complications to patients during surgery.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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