Recall
FDAHealthJune 16, 2025

Draeger, Inc. — SafeStar 90 Plus Filter. Bidirectionally breathing system filter.

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 16, 2025

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.

What's affected?

Product
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Lot code
s

Additional details

Model No. MP05785; UDI: 04048675665762; All Lots.

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 669,838 units.

View original FDA notice →

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