Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog… — Class I medical device recall Z-1493-2025
Ongoing recall by Draeger, Inc., reported 2025-04-09, distributed nationwide. The potential for cracks forming in the breathing circuit hose.
| Recall number | Z-1493-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger, Inc., Telford, PA, United States |
| Recall initiated | 2025-03-12 |
| Classified | 2025-04-03 |
| Reported by FDA | 2025-04-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BG, CN, CZ, DE, ES, FR, GB, GH, GR, GT, HR, HU, IN, IT, JP, PA, PH, PT, SE, SG, ZA |
| Quantity | 65,150 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04048675248996 |
| Model numbers | MP00355 |
Product
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not applicable
Reason for recall
The potential for cracks forming in the breathing circuit hose.
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-1493-2025. 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.