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

Recalled August 6, 2025 · FDA recall Z-2160-2025 · Draeger

Hazard

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

Units

1,019,782 units

Sold at

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, Bulgaria, Burkina-Faso, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., El Salvador, Faeroe, France, French Guiana, Gabon, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Vietnam.

Description

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

Product

HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.

Manufacturer(s)

Draeger, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →