Carina Ventilator — Class II medical device recall Z-1954-2018
Terminated recall by Draeger Medical, Inc., reported 2018-06-06, distributed in CT, IL, MN, NV, SD, WA. The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of
| Recall number | Z-1954-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2018-04-26 |
| Classified | 2018-05-29 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2018-09-07 |
| Distributed | CT, IL, MN, NV, SD, WA |
| Quantity | 8 units |
| Serial numbers | ASKM-0065, ASKM-0066, ASKM-0106, ASKM-0134, ASKM-0137, ASKM-0150, ASKM-0151, ASKN-0009 |
| Model numbers | 5704110 |
Product
Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
Reason for recall
The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1954-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.