NovaStar TS — Class I medical device recall Z-1137-2023
Ongoing recall by Draeger Medical, Inc., reported 2023-03-01, distributed nationwide. The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted a
| Recall number | Z-1137-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2023-01-23 |
| Classified | 2023-02-23 |
| Reported by FDA | 2023-03-01 |
| Distributed | Nationwide (US) |
| Quantity | 16 units |
| UPC / GTIN / UDI-DI | 04048675041146, 04048675041153, 04048675041160 |
Product
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
Reason for recall
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
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-1137-2023. 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.