FDA Device recall Z-1138-2023
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
- FDA Device
- Class I
- ongoing
- Published 2023-03-01
On 2023-03-01 the FDA classified a Class I recall of NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L) by Draeger Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1138-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-01-23 |
| Published | 2023-03-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Draeger Medical |
| Distribution | US |
Product
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Reason
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.
Identifiers
| code_info | All Lot numbers. UDI-DI: 04048675040552 (MP01579); 04048675040569 (MP01580); 04048675040538 (MP01581) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1138-2023%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.