Getinge Usa Sales Inc recalls Vaporizer Sevoflurane

Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.

Getinge notified consignees on 01/15/2024 via URGENT MEDICAL DEVICE RECALL letter. Consignees were provided additional information which is complementary to the existing user manual and were instructed to ensure all affected product inventory has been quarantined, consignees are entitled to credit/replacement, the recall information is forwarded to affected personnel and any customers if it was further distributed and complete and return the provided URGENT MEDICAL DEVICE RECALL RESPONSE FORM.

• FDA enforcement recordOfficial FDA database entry for Z-1074-2025
• FDA 510(k) clearance · K191027The device's official FDA premarket clearance record
• FDA device classification · BSZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5160The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Getinge Usa Sales IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.