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SafeStar 55 Plus Filter. Bidirectionally breathing system… recallZ-2159-2025 · Draeger, Inc. · initiated Jun 16, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Draeger, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-2159-2025
Status
Open, Classified
Initiated by the company
Jun 16, 2025
Posted by the FDA
Jul 31, 2025
Recalling firm
Draeger, Inc.
Quantity
9,885,139 units
Product code
CAH
FDA submissions
K221836
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 description

SafeStar 55 Plus Filter. Bidirectionally breathing system filter.

Code information (models, lots, serial numbers)

Mode No. MP05790; UDI: 04048675558736; All Lots.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

3 devices cleared under K221836 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97026).

Sources and updates

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