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Draeger, Inc. recalls SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Recalled August 6, 2025 · FDA recall Z-2158-2025 · 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
669,838 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
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Manufacturer(s)
Draeger, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →