FDA Medical devices recall ·
Natus Brain Monitor Breakout Box, Part Number 021911 recall
- Recall number
- Z-2138-2025
- Date
- (initiated June 18, 2025)
- Company / brand
- Excel Tech.
2568 Bristol Cir, Oakville, N/A, Canada - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 27 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Why was it recalled?
Natus received two complaints of left side labeling show impedance for right side.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
US: CA, IN, MO, NC, PA, RI, TX
States: California Indiana Missouri North Carolina Pennsylvania Rhode Island Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2138-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.