Draeger Carina Sub-Acute Care Ventilator Recall: Pediatric Chemical Risk
Draeger Medical recalls pediatric ventilators due to chemical emissions exceeding safe levels during long-term use. Affected units may pose health risks for children.
Lower-risk recall
Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
Contact the company
What happened, in plain English
Dra: Draeger Medical is recalling pediatric ventilators that could emit harmful chemicals when used for more than 30 days. This poses a health risk for children using the device long-term. Read more at govinfonow.com/recall/57695-draeger-carina-sub-acute-care-ventilator-recall-pediatric-chemical-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/57695-draeger-carina-sub-acute-care-ventilator-recall-pediatric-chemical-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2248-2023
Cite this page
“Draeger Carina Sub-Acute Care Ventilator Recall: Pediatric Chemical Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/57695-draeger-carina-sub-acute-care-ventilator-recall-pediatric-chemical-risk. Based on FDA recall #Z-2248-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2248-2023%22&limit=1).
Why it’s dangerous
The ventilator emits a chemical called 1,3-Dichloropropan-2-ol that exceeds safe levels when used continuously for more than 30 days in children. This chemical buildup could cause health issues over time.
Who’s affected
Pediatric patients using the Carina Sub-Acute Care Ventilator for extended periods (over 30 days) are at risk. Parents and caregivers of children with breathing issues are most affected.
How to tell if you have this one
Check for the model number 5704110 or the UDI-DI code 04048675398516 on the ventilator. All units with this specific serial number range are affected.
- Brand
Draeger Medical- Category
Medical device
What to do — step by step
Check Product Details
Identify the model number 5704110 or UDI-DI code 04048675398516 on the ventilator.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 49 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-2248-2023 (July 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2248-2023 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.