Getinge Usa Sales Inc: Medical Device Recall in 2025 - (Recall #: Z-1074-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.

Product Classification:

Class I

Date Initiated: January 15, 2025

Date Posted: February 19, 2025

Recall Number: Z-1074-2025

Event ID: 96083

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 6 units

Code Information:

Model Number: 6682285. UDI-DI: 07325710001141. Serial Numbers: 3761, 7635, 7633, 7630, 7632, 7631.

Distribution Pattern:

Domestic distribution to Kentucky and Connecticut.

Voluntary or Mandated:

Voluntary: Firm initiated