The FDA has posted 6 enforcement recalls of general & plastic surgery laparoscope devices since 2025, none of them Class I (most serious). Most recent report: Jan 14, 2026.
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Laparoscope, General & Plastic Surgery”). Informational only — verify against the FDA before acting.