SafeStar 55 Plus Filter (Draeger) – CO2 Sampling Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Brand
Draeger, Inc.
Lot Codes / Batch Numbers
Mode No. MP05790, UDI: 04048675558736, All Lots.
Products Sold
Mode No. MP05790; UDI: 04048675558736; All Lots.
Draeger, Inc. is recalling SafeStar 55 Plus Filter. Bidirectionally breathing system filter. due to Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026