Z-2159-2025Class I

SafeStar 55 Plus Filter. Bidirectionally breathing system filter

Name: Z-2159-2025 SafeStar 55 Plus Filter. Bidirectionally breathing system filter
Creator: Draeger, Inc.
Published: 2025-06-16
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2025-06-16 / Open, Classified / root cause: manufacturing process

FDA source

Draeger, Inc. began a recall of SafeStar 55 Plus Filter. Bidirectionally breathing system filter on 2025-06-16. FDA classified it as Class I and gives the reason as "Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2159-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-06-16
Posted: 2025-07-31
Recalling firm: Draeger, Inc.
Product: SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Product code: CAH Filter, Bacterial, Breathing-Circuit
Reason for recall: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Root cause tag: manufacturing process
FDA 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 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 [email protected]. 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 [email protected] to coordinate return/replacement. This recall notification should be shared with all users and forwarded to where devices were further distributed.
Quantity in commerce: 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, Bulgaria, Burkina-Faso, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., El Salvador, Faeroe, France, French Guiana, Gabon, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Vietnam.
Product codes and lots: Mode No. MP05790; UDI: 04048675558736; All Lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2159-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2158-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31
Z-2159-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31
Z-2160-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31
Z-2161-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31

Product code CAH

K221836Class IIFilter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA / cleared 2022-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)