Draeger SafeStar 9: CO2 Curve Increase Risk in Filters
Draeger recalls SafeStar 90 Plus filters due to potential CO2 curve increases during gas sampling. Affected units include all lots of model MP05785.
Lower-risk recall
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Contact the company
What happened, in plain English
Draeger is recalling SafeStar 90 Plus filters because they may show a slow increase in CO2 levels when gas is sampled. This could affect breathing safety in medical devices. The recall covers all lots of the specific filter model. Read more at govinfonow.com/recall/52034-draeger-safestar-9-co2-curve-increase-risk-in-filters.
Source Summary by GovInfoNow · govinfonow.com/recall/52034-draeger-safestar-9-co2-curve-increase-risk-in-filters · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2158-2025
Cite this page
“Draeger SafeStar 9: CO2 Curve Increase Risk in Filters.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/52034-draeger-safestar-9-co2-curve-increase-risk-in-filters. Based on FDA recall #Z-2158-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2158-2025%22&limit=1).
Why it’s dangerous
The filter may cause a slow rise in CO2 levels when gas is sampled from the sampling port. This could lead to inaccurate readings in medical monitoring systems. However, the risk is not immediate or severe under normal use conditions.
Who’s affected
Users of SafeStar 90 Plus breathing systems with the recalled filter model are affected. Healthcare providers using these filters for medical purposes are most at risk.
How to tell if you have this one
Check for the model number MP05785 on the filter. The recall applies to all lots of this filter. The filter is part of the SafeStar 90 Plus bidirectional breathing system.
- Brand
Draeger- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2158-2025 | SafeStar 90 Plus Filter. Bidirectionally breathing system filter.; Model No. MP05785; UDI: 04048675665762; All Lots. | 669,838 units |
| Z-2159-2025 | SafeStar 55 Plus Filter. Bidirectionally breathing system filter.; Mode No. MP05790; UDI: 04048675558736; All Lots. | 9,885,139 units |
| Z-2160-2025 | HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.; Model No. MP05801; UDI: 04048675665823; All Lots. | 1,019,782 units |
| Z-2161-2025 | SafeStar 60A Plus Filter. Bidirectionally breathing system filter.; Model No. MP05795; UDI: 04048675665786; All Lots. | 374,700 units |
What to do — step by step
Check Filter Model
Identify the model number on the filter to confirm it is MP05785.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 29 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Mexico, New York, North Carolina, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2158-2025 (June 16, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2158-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.