PlainRecordsFDA · Medical device recall
SafeStar 90 Plus Filter… and 3 more products
- Reason
- Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- Status
- Ongoing
- 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…
- Enforcement report date
- Aug. 6, 2025
- Risk class
- Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Draeger, Inc.
- Reason
- Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
- 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.
What this record is about
A generic icon of the kind of thing the record is about; the record's own words are below. It is not a picture of the product.
“Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.”SafeStar 90 Plus Filter. Bidirectionally breathing system filter., FDA enforcement report, 2025-08-06. The caption is the record's own words.
The picture shows the kind of thing the record is about (a part, a product, a package), not the product itself; the ring marks it. Nothing in it is a claim beyond the record's own words below.
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FDA device name: Filter, Bacterial, Breathing-Circuit
Distributed in (FDA's record): Alaska Arizona California Colorado Connecticut Florida Idaho Illinois Indiana Louisiana Maine Massachusetts Michigan Minnesota Missouri Nebraska Nevada New Mexico New York North Carolina Ohio Pennsylvania South Dakota Tennessee Texas Utah Washington Wisconsin Wyoming and nationwide
4 products in this recall
SafeStar 90 Plus Filter…
- Product
- SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
- Quantity
- 669,838 units
- Codes and lots
- Model No. MP05785; UDI: 04048675665762; All Lots.
- Recall started
- June 16, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Filter, Bacterial, Breathing-Circuit
- Root cause (FDA)
- Process control
- What the company told customers
- An initial Urgent Medical Device Recall notification dated June 2025 was mailed to consignees. The notification instructs consignees to not make therapeutic decisions based solely on individual measured values or parameters, regardless of the measuring point and the ventilator or anesthesia machine used. Consignees are to not connect the sample line to the filter sampling port; if an alternative sample port is not feasible, the firm requests that consignees use an alternative filter. All users of affected devices are to be notified of this recall notice and the notice forwarded to customers to which product was further distributed. Consignees are asked to complete and return the provided Response Acknowledgement and Receipt Form. Questions can be directed to Michael Kelhart at 267-664-1131 from 8:00 AM EST to 4:30 PM EST, or by email at mike.kelhart@draeger.com. A second Urgent Medical Device Recall notification dated July 2025 was mailed to consignees. This notification recommends that any unused filters affected by this recall not be used and any unused stock should be removed. Consignees are to contact their local Draeger Representative for information regarding alternatives. Draeger Customer Success can be contacted at 1-800-437-2437 (option 2, option 1) or US-Medical@draeger.com to coordinate return/replacement. This recall notification should be shared with all users and forwarded to where devices were further distributed.
- Recall number
- Z-2158-2025
SafeStar 55 Plus Filter…
- Product
- SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
- Quantity
- 9,885,139 units
- Codes and lots
- Mode No. MP05790; UDI: 04048675558736; All Lots.
- Recall started
- June 16, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Filter, Bacterial, Breathing-Circuit
- Root cause (FDA)
- Process control
- What the company told customers
- An initial Urgent Medical Device Recall notification dated June 2025 was mailed to consignees. The notification instructs consignees to not make therapeutic decisions based solely on individual measured values or parameters, regardless of the measuring point and the ventilator or anesthesia machine used. Consignees are to not connect the sample line to the filter sampling port; if an alternative sample port is not feasible, the firm requests that consignees use an alternative filter. All users of affected devices are to be notified of this recall notice and the notice forwarded to customers to which product was further distributed. Consignees are asked to complete and return the provided Response Acknowledgement and Receipt Form. Questions can be directed to Michael Kelhart at 267-664-1131 from 8:00 AM EST to 4:30 PM EST, or by email at mike.kelhart@draeger.com. A second Urgent Medical Device Recall notification dated July 2025 was mailed to consignees. This notification recommends that any unused filters affected by this recall not be used and any unused stock should be removed. Consignees are to contact their local Draeger Representative for information regarding alternatives. Draeger Customer Success can be contacted at 1-800-437-2437 (option 2, option 1) or US-Medical@draeger.com to coordinate return/replacement. This recall notification should be shared with all users and forwarded to where devices were further distributed.
- Recall number
- Z-2159-2025
HME TwinStar HEPA Plus Filter…
- Product
- HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
- Quantity
- 1,019,782 units
- Codes and lots
- Model No. MP05801; UDI: 04048675665823; All Lots.
- Recall started
- June 16, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Filter, Bacterial, Breathing-Circuit
- Root cause (FDA)
- Process control
- What the company told customers
- An initial Urgent Medical Device Recall notification dated June 2025 was mailed to consignees. The notification instructs consignees to not make therapeutic decisions based solely on individual measured values or parameters, regardless of the measuring point and the ventilator or anesthesia machine used. Consignees are to not connect the sample line to the filter sampling port; if an alternative sample port is not feasible, the firm requests that consignees use an alternative filter. All users of affected devices are to be notified of this recall notice and the notice forwarded to customers to which product was further distributed. Consignees are asked to complete and return the provided Response Acknowledgement and Receipt Form. Questions can be directed to Michael Kelhart at 267-664-1131 from 8:00 AM EST to 4:30 PM EST, or by email at mike.kelhart@draeger.com. A second Urgent Medical Device Recall notification dated July 2025 was mailed to consignees. This notification recommends that any unused filters affected by this recall not be used and any unused stock should be removed. Consignees are to contact their local Draeger Representative for information regarding alternatives. Draeger Customer Success can be contacted at 1-800-437-2437 (option 2, option 1) or US-Medical@draeger.com to coordinate return/replacement. This recall notification should be shared with all users and forwarded to where devices were further distributed.
- Recall number
- Z-2160-2025
SafeStar 60A Plus Filter…
- Product
- SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
- Quantity
- 374,700 units
- Codes and lots
- Model No. MP05795; UDI: 04048675665786; All Lots.
- Recall started
- June 16, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Filter, Bacterial, Breathing-Circuit
- Root cause (FDA)
- Process control
- What the company told customers
- An initial Urgent Medical Device Recall notification dated June 2025 was mailed to consignees. The notification instructs consignees to not make therapeutic decisions based solely on individual measured values or parameters, regardless of the measuring point and the ventilator or anesthesia machine used. Consignees are to not connect the sample line to the filter sampling port; if an alternative sample port is not feasible, the firm requests that consignees use an alternative filter. All users of affected devices are to be notified of this recall notice and the notice forwarded to customers to which product was further distributed. Consignees are asked to complete and return the provided Response Acknowledgement and Receipt Form. Questions can be directed to Michael Kelhart at 267-664-1131 from 8:00 AM EST to 4:30 PM EST, or by email at mike.kelhart@draeger.com. A second Urgent Medical Device Recall notification dated July 2025 was mailed to consignees. This notification recommends that any unused filters affected by this recall not be used and any unused stock should be removed. Consignees are to contact their local Draeger Representative for information regarding alternatives. Draeger Customer Success can be contacted at 1-800-437-2437 (option 2, option 1) or US-Medical@draeger.com to coordinate return/replacement. This recall notification should be shared with all users and forwarded to where devices were further distributed.
- Recall number
- Z-2161-2025
This recall among the others
- FDA's enforcement report came 51 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- Draeger: 1 other recall or notice on this site in the three years before this one (from Aug. 7, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-2158-2025, Z-2159-2025, Z-2160-2025, Z-2161-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-2158-2025, Aug. 6, 2025. "SafeStar 90 Plus Filter… and 3 more products." PlainRecords, https://plainrecords.com/recall/device/z-2158-2025/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections