Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported August 6, 2025
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Draeger, Inc. recalled SafeStar 55 Plus Filter. Bidirectionally breathing system filter. - a critical-severity action.
SafeStar 55 Plus Filter. Bidirectionally breathing system filter. was recalled by Draeger, Inc. in August 6, 2025. Reason: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.. Check the official notice for the remedy. Verify recall #Z-2159-2025 with the FDA Devices before acting.
The recall
Draeger, Inc. issued this critical-severity FDA Devices recall-Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters..
- Critical
- severity level
- 9.9M units
- affected scope
- Class I
- classification
- August 6, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2159-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2159-2025) was formally reported on August 6, 2025, with the manufacturer initiating the action on June 16, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Draeger, Inc. is listed as the recalling firm, operating out of Telford, PA. Federal records list the affected scope as 9,885,139 units, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. Distribution data in the federal record shows the product reached: 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, Arge…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
9,885,139 units
Related Recalls
6
3 from same agency
Product description
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Reason for recall
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-2159-2025 |
| Date reported | August 6, 2025 |
| Date initiated | June 16, 2025 |
| Recalling firm | Draeger, Inc. |
| Firm location | Telford, PA |
| Affected scope | 9,885,139 units |
| 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, Au… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2159-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.. Recalled by Draeger, Inc.. Units affected: 9,885,139 units.
Why was this product recalled? ▼
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 6, 2025. Severity: Critical. Recall number: Z-2159-2025.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2159-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 6, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.