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Recall Observatory FDA recall evidence

Device product

SafeStar 90 Plus Filter. Bidirectionally breathing system filter.

Z-2158-2025

June 16, 2025

Class I

Product summary

Firm
Draeger, Inc.
Event
Event 97026
Status
Ongoing
Classification
Class I
Quantity
669,838 units
Official record key
device-enforcement:Z-2158-2025

Official wording

Reason: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Code information: Model No. MP05785; UDI: 04048675665762; All Lots.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.