Natus Brain Monitor Breakout Box recall: Labeling Error
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Why was Natus Brain Monitor Breakout Box recalled?
Natus received two complaints of left side labeling show impedance for right side.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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.
- Product
- Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
- Recalling firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Quantity
- 27 units
- Distribution
- US: CA, IN, MO, NC, PA, RI, TX
- Recall date
- July 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)