Draeger, Inc. recalls SafeStar 60A 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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2161-2025
• FDA 510(k) clearance · K221836The device's official FDA premarket clearance record
• FDA device classification · CAHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5260The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Draeger, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.