Draeger SafeStar 55: Filter Occlusion Risk from Manufacturing Error
Draeger Medical recalls SafeStar 55 oxygen monitors with possible filter blockage due to manufacturing error. Affected units have specific catalog and lot numbers. No remedy stated in recall notice.
Recall notice
Possible occlusion of filters due to manufacturing error.
Contact the company
What happened, in plain English
Dra: Draeger Medical is recalling SafeStar 55 oxygen monitors that may have filters blocked by a manufacturing error. This could cause the device to malfunction during use, but the recall does not specify a fix or deadline. Read more at govinfonow.com/recall/60699-draeger-safestar-55-filter-occlusion-risk-from-manufacturing-error.
Source Summary by GovInfoNow · govinfonow.com/recall/60699-draeger-safestar-55-filter-occlusion-risk-from-manufacturing-error · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1211-2022
Cite this page
“Draeger SafeStar 55: Filter Occlusion Risk from Manufacturing Error.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/60699-draeger-safestar-55-filter-occlusion-risk-from-manufacturing-error. Based on FDA recall #Z-1211-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1211-2022%22&limit=1).
Why it’s dangerous
The filters in these oxygen monitors may become blocked due to a manufacturing error, which could lead to improper oxygen delivery. This might cause the device to malfunction during critical medical use.
Who’s affected
Oxygen monitoring devices used in medical settings, particularly those with the catalog number MP01790 and lot number LT2103. Healthcare providers and patients using these devices are most at risk.
How to tell if you have this one
Check for the catalog number MP01790 and lot number LT2103 on the device. The UDI-DI code 04048675026785 is also associated with this recall.
- Brand
Draeger Medical- Category
Medical device
What to do — step by step
Check Device Details
Look for the catalog number MP01790 and lot number LT2103 on the device.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 24 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Tennessee, Texas, Washington, West Virginia.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1211-2022 (May 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1211-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.