FDA Device recall Z-2138-2025
Natus Brain Monitor Breakout Box, Part Number 021911
- FDA Device
- Class II
- ongoing
- Published 2025-07-30
On 2025-07-30 the FDA classified a Class II recall of Natus Brain Monitor Breakout Box, Part Number 021911 by Natus Neurology, citing natus received two complaints of left side labeling show impedance for right side.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2138-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-18 |
| Published | 2025-07-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Natus Neurology |
| Distribution | CA, IN, MO, NC, PA, RI, TX |
Product
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Reason
Natus received two complaints of left side labeling show impedance for right side.
Identifiers
| code_info | UDI/DI 038283NA00153ED, Serial Numbers: 021918100008-M, 021918100014-M, 021918100015-M, 021918100017-M, 021918100019-M…UDI/DI 038283NA00153ED, 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, 021918100054-M, 021918100055-M. |
|---|
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-2138-2025%22
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