Draeger, Inc. 2025-08-06 Health critical FDA
Health · FDA · Recall #FDA-Z-2158-2025
SafeStar 90 Plus Filter. Bidirectionally breathing system filter. Recall
Issued August 6, 2025 · Draeger, Inc.
In August 2025, Draeger, Inc. recalled the SafeStar 90 Plus Filter. Bidirectionally breathing system filter., a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
What you should do
- 1 Stop using SafeStar 90 Plus Filter. Bidirectionally breathing system filter. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Draeger, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Draeger, Inc.
- Category
- Health
- Recall date
- August 6, 2025
- Units affected
- Not reported
- 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, N
- Recall number
- FDA-Z-2158-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Draeger, Inc. has 2 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.