Draeger, Inc. medical device recall: SafeStar 90 Plus Filter. Bidirectionally breathing system filter
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97026
- Recall initiated
- Jun 16, 2025
- Classified by FDA
- Jul 31, 2025
- Posted in Enforcement Report
- Aug 6, 2025
- Recalling firm
- Draeger, Inc.
- Firm location
- Telford, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 4
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jun 16, 2025. FDA classified it 45 days later, on Jul 31, 2025. This recall event covers 4 separate products, each with its own FDA recall number. Distribution reported by FDA: 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,… Draeger, Inc. has 7 recalls in our records.
Recalled products (4)
Z-2158-2025 Class I Ongoing
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Codes / lots: Model No. MP05785; UDI: 04048675665762; All Lots.
Quantity: 669,838 units
Z-2159-2025 Class I Ongoing
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Codes / lots: Mode No. MP05790; UDI: 04048675558736; All Lots.
Quantity: 9,885,139 units
Z-2160-2025 Class I Ongoing
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
Codes / lots: Model No. MP05801; UDI: 04048675665823; All Lots.
Quantity: 1,019,782 units
Z-2161-2025 Class I Ongoing
SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
Codes / lots: Model No. MP05795; UDI: 04048675665786; All Lots.
Quantity: 374,700 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97026
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.