Recall Z-2158-2025— Draeger, Inc.

Name: FDA recall Z-2158-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-16

Class I · Ongoing

Class I FDA medical device recall by Draeger, Inc., initiated 2025-06-16. It names one FDA 510(k) clearance: K221836. Product: SafeStar 90 Plus Filter. Bidirectionally breathing system filter.. Reason: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters..

Recalling firm: Draeger, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-06-16
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA·cleared 2022-12-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SafeStar 90 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.