Draeger, Inc. recalls HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.

Recall date

June 16, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2160-2025

FDA classification

Class I

Brand / firm

Draeger, Inc.

Sold / distributed

Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, ID, IL, IN, KAS, LA, MA, ME, MI, MN, MO, NC, NE, NM, NV, NY, OH, PA, SD, TN, TX, UT, WA, WI, WY and the countries of Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Bulg…

Why it was recalled

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.