The FDA has posted 15 enforcement recalls of laparoscopic insufflator devices since 2025, including 3 Class I (most serious) recalls. Most recent report: Jul 29, 2026.
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Potential for overpressure alerts.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Insufflator, Laparoscopic”). Informational only — verify against the FDA before acting.