Data Foundry

Medical device recalls 2025

Vaporizer Sevoflurane — Class I medical device recall Z-1074-2025

Ongoing recall by Getinge Usa Sales Inc, reported 2025-02-19, distributed in CT, KY. Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients o

Recall numberZ-1074-2025
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmGetinge Usa Sales Inc, Wayne, NJ, United States
Recall initiated2025-01-15
Classified2025-02-07
Reported by FDA2025-02-19
DistributedCT, KY
Quantity6 units
UPC / GTIN / UDI-DI07325710001141
Serial numbers3761, 7630, 7631, 7632, 7633, 7635
Model numbers6682285

Product

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1074-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.