SafeStar 60A Plus Filter. Bidirectionally breathing system filter.

Recall Insight

This FDA Devices action (record #Z-2161-2025) 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 indicate 374,700 units units are affected, a scale large enough to require multi-state distribution tracking.

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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.