CLASS II ONGOING Device recall · Reported 30 Jul 2025 · FDA Enforcement Report

Natus Brain Monitor Breakout recalled by Natus Neurology

Natus Neurology is recalling Natus Brain Monitor Breakout, distributed in 7 states. The recall was initiated on 18 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/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.

Quantity recalled27 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2138-2025
FDA event ID: 97091
Recalling firm: Natus Neurology, Oakville, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 18 Jun 2025
FDA classified: 18 Jul 2025
Reported: 30 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

18 Jun 2025	Recall initiated by company
18 Jul 2025	Classified by FDA	+30 days
30 Jul 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Natus received two complaints of left side labeling show impedance for right side.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph

Where it was distributed

US: CA, IN, MO, NC, PA, RI, TX

California Indiana Missouri North Carolina Pennsylvania Rhode Island Texas

Questions about this recall

Why was it recalled?

Natus received two complaints of left side labeling show impedance for right side.

Which lots are affected?

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.

Where was it sold?

US: CA, IN, MO, NC, PA, RI, TX

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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