Natus Brain Monitor Breakout Box — Class II medical device recall Z-2138-2025
Ongoing recall by Natus Neurology DBA Excel Tech., Ltd. (XLTEK), reported 2025-07-30, distributed in CA, IN, MO, NC, PA, RI, TX. Natus received two complaints of left side labeling show impedance for right side.
| Recall number | Z-2138-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Neurology DBA Excel Tech., Ltd. (XLTEK), Oakville, N/A, Canada |
| Recall initiated | 2025-06-18 |
| Classified | 2025-07-18 |
| Reported by FDA | 2025-07-30 |
| Distributed | CA, IN, MO, NC, PA, RI, TX |
| Quantity | 27 units |
| Reason classes | labeling |
| Serial numbers | 021918100008-M, 021918100014-M, 021918100015-M, 021918100017-M, 021918100019-M, 021918100020-M, 021918100021-M, 021918100025-M, 021918100026-M, 021918100028-M, 021918100032-M, 021918100034-M, 021918100036-M, 021918100038-M, 021918100039-M, 021918100040-M, 021918100041-M, 021918100044-M, 021918100046-M, 021918100047-M, 021918100048-M, 021918100049-M, 021918100050-M, 021918100051-M, 021918100052-M and 2 more |
| Model numbers | 021911 |
Product
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Reason for recall
Natus received two complaints of left side labeling show impedance for right side.
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-2138-2025. 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.