FDA Medical devices recall ·
SafeStar 60A Plus Filter recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2161-2025
- Date
- (initiated June 16, 2025)
- Company / brand
- Draeger, Inc.
3135 Quarry Rd, Telford, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 374,700 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
Why was it recalled?
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. MP05795; UDI: 04048675665786; All Lots.
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.
States: Alaska Arizona California Colorado Connecticut Florida Idaho Illinois Indiana Louisiana Massachusetts Maine Michigan Minnesota Missouri North Carolina Nebraska New Mexico Nevada New York Ohio Pennsylvania South Dakota Tennessee Texas Utah Washington Wisconsin Wyoming
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2161-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.