Draeger, Inc.: Device Recall

Recall #Z-2160-2025 · 06/16/2025

Class I: Dangerous

Recall Details

Recall Number
Z-2160-2025
Classification
Class I
Product Type
Device
Recalling Firm
Draeger, Inc.
Status
Ongoing
Date Initiated
06/16/2025
Location
Telford, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,019,782 units

Reason for Recall

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

Product Description

HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.

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.

Other Recalls by Draeger, Inc.

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.