VentStar Basic — Class II medical device recall Z-1178-2021
Terminated recall by Draeger Medical, Inc., reported 2021-03-17, distributed nationwide. Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak
| Recall number | Z-1178-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2021-01-29 |
| Classified | 2021-03-05 |
| Reported by FDA | 2021-03-17 |
| Terminated | 2021-11-01 |
| Distributed | Nationwide (US) |
| Quantity | 1,525 units |
| Reason classes | packaging, device malfunction |
Product
VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
Reason for recall
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
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-1178-2021. 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.