Recall Z-2159-2025 · CAH Filter, Bacterial, Breathing-Circuit
Draeger, Inc.
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
| Date | Jul 31, 2025 (initiated Jun 16, 2025) |
| Status | Open, Classified |
| Reason | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 9,885,139 units |
| 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, Belgium, Bolivia, Bosnia-Herz., Brazil, Bulga |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus Drägerwerk AG & Co. KGaA, Dec 7, 2022 |