# FDA recall Z-1211-2022

> **Draeger Medical, Inc.** · Class I · device recall initiated 2022-05-16.

## Product

Drager SafeStar 55, Catalog No. MP01790

## Reason for recall

Possible occlusion of filters due to manufacturing error.

## Distribution

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.

## Key facts

- **Recall number:** Z-1211-2022
- **Recalling firm:** Draeger Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-16
- **Report date:** 2022-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Telford, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1211-2022

## Citation

> AI Analytics. FDA recall Z-1211-2022. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1211-2022. Source: US FDA. Licensed CC0.

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