Oxylog 3000 — Class I medical device recall Z-2215-2016
Terminated recall by Draeger Medical, Inc., reported 2016-08-10, distributed nationwide. Isolated episodes of leakage at the check valve were found
| Recall number | Z-2215-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2016-05-31 |
| Classified | 2016-08-04 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2018-03-14 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| Model numbers | 5704964 |
Product
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.
Reason for recall
Isolated episodes of leakage at the check valve were found
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-2215-2016. 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.