Draeger Medical, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1211-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Drager SafeStar 55, Catalog No. MP01790

Product Classification:

Class I

Date Initiated: May 16, 2022

Date Posted: June 22, 2022

Recall Number: Z-1211-2022

Event ID: 90192

Reason for Recall:

Possible occlusion of filters due to manufacturing error.

Status: Ongoing

Product Quantity: 35,950

Code Information:

UDI-DI: 04048675026785; Lot No. LT2103.

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NC, ND, NV, NY, OH, PA, TN, TX, WA, and WV. The countries of Austria, Belgium, Bulgaria, Canada, Columbia, Croatia, Czech Republic, Denmark, France, Germany, India, Indonesia, Ireland, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Malaysia, Morocco, Netherlands, Norway, Philippines, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Suriname, Sweden, Switzerland, Thailand, United Kingdom, and United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated