SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Reported: August 6, 2025 Initiated: June 16, 2025 #Z-2158-2025
Product Description
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Reason for Recall
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Details
- Recalling Firm
- Draeger, Inc.
- Units Affected
- 669,838 units
- Distribution
- 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.
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.. Recalled by Draeger, Inc.. Units affected: 669,838 units.
Why was this product recalled? ▼
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 6, 2025. Severity: Critical. Recall number: Z-2158-2025.
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