FDAFDA · Food and drugs·Recall number Z-2158-2025
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Published August 6, 2025 · Recall initiated: June 16, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Draeger, Inc.
- Distributor
- 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.
- Lot
- Model No. MP05785; UDI: 04048675665762; All Lots.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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