Summary
The FDA issued a Class I for SafeStar 90 Plus Filter. Bidirectionally breathing system filter. by Draeger, Inc.. Reason: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters..
Details
Source
Device Recall
External ID
Z-2158-2025
Action Date
2025-08-06
Status
Ongoing
Category
device
Product Description
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Lot/Code Info: Model No. MP05785; UDI: 04048675665762; All Lots.
Quantity Affected: 669,838 units
Reason for Recall
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-16
Company
Telford, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Draeger, Inc. has 21 FDA actions in our database, including 21 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Draeger, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Draeger, Inc. have FDA actions?
Draeger, Inc. has 21 FDA actions in our database, including 21 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2158-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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