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HIFClass 2

Insufflator, Laparoscopic

FDA adverse event reports and recall history for insufflator, laparoscopic (product code HIF), from the public MAUDE corpus and the live FDA recall database.

Total reports
7,499
Deaths
34
Injuries
816
Malfunctions
6,605

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 20122026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

  • 2026-07-22Open, ClassifiedNonconforming Material/Component

    Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

    Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

  • 2026-06-17Open, ClassifiedProcess change control

    ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy

    Potential for overpressure alerts.

  • 2026-06-17Open, ClassifiedProcess change control

    ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    Potential for overpressure alerts.

  • 2026-06-17Open, ClassifiedProcess change control

    ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    Potential for overpressure alerts.

  • 2026-06-17Open, ClassifiedProcess change control

    ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS8-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    Potential for overpressure alerts.

  • 2026-06-17Open, ClassifiedProcess change control

    ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    Potential for overpressure alerts.

  • 2026-06-17Open, ClassifiedProcess change control

    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    Potential for overpressure alerts.

  • 2026-06-17Open, ClassifiedProcess change control

    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    Potential for overpressure alerts.

  • 2026-06-17Open, ClassifiedProcess change control

    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    Potential for overpressure alerts.

  • 2026-06-17Open, ClassifiedProcess change control

    ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    Potential for overpressure alerts.

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