EDS 3 CSF External Drainage System — Class II medical device recall Z-0635-2024
Ongoing recall by Natus Medical Incorporated, reported 2024-01-10, distributed nationwide. Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
| Recall number | Z-0635-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Medical Incorporated, San Diego, CA, United States |
| Recall initiated | 2023-11-28 |
| Classified | 2024-01-04 |
| Reported by FDA | 2024-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 3,336 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00382830050555 |
| Lot numbers | 1FX0004588937, 1FX0004588938, 1FX0004588939, 1FX0004663824, 1FX0004663825, 1FX0004663826, 1FX0004663827, 1FX0004663828, 1FX0004663829, 1FX0004663830, 1FX0004763454, 1FX0004763455, 1FX0004763456, 1FX0004763457, 1FX0004763458, 1FX0004763459, 1FX0004763460, 1FX0004763461, 1FX0004763462, 1FX0004763463, 1FX0004763464, 1FX0004763465, 1FX0004833126, 1FX0004833127, 1FX0004833136, 1FX0004833139, 1FX0004833140, 1FX0004833141, 1FX0004857869, 1FX0004857870, 1FX0004857871, 1FX0004857872, 1FX0004857873, 1FX0004857874, 1FX0004857875, 1FX0004857876, 1FX0004857877, 1FX0004857878, 1FX0004857879, 1FX0004857880 and 9 more |
| Model numbers | NT821731C |
Product
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Reason for recall
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
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-0635-2024. 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.