Olympus Corporation of the Americas is recalling 1,247 High Flow Insufflation Units, including models UHI, UHI-2, and UHI-3. These medical devices are used during laparoscopic surgeries to inflate the abdominal cavity and manage smoke evacuation. A defect in the software algorithm can cause overpressure events, which may lead to serious complications during surgical procedures. Owners of these units should contact Olympus or their distributor to arrange for a correction or return of the affected equipment.
A software algorithm error can cause the device to provide excessive pressure within the patient's abdominal cavity. This overpressurization poses a risk of air embolism or other internal injuries during surgery.
Recall #: Z-1352-2026; 18 units affected.
Recall #: Z-1353-2026; 744 units affected.
Recall #: Z-1354-2026; 485 units affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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