FDA Device recall Z-1493-2025
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Br…
- FDA Device
- Class I
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class I recall of Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Br… by Draeger, citing the potential for cracks forming in the breathing circuit hose.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1493-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-03-12 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Draeger |
| Distribution | US |
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
The potential for cracks forming in the breathing circuit hose.
Identifiers
| code_info | Model/Catalog Number: MP00355; UDI Number 04048675248996; All lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1493-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.