Lower riskMedical device recall · FDA · Published June 18, 2025
Natus Brain Monitor Breakout Box Recall: Left Side Labeling Error
Natus recalls specific Brain Monitor Breakout Boxes with left side labeling showing right side impedance. This error may cause misinterpretation of brain wave readings during use.
“Natus Brain Monitor Breakout Box Recall: Left Side Labeling Error.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52020-natus-brain-monitor-breakout-box-recall-left-side-labeling-error. Based on FDA recall #Z-2138-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2138-2025%22&limit=1).
The FDA announced on June 18, 2025, that Natus Neurology DBA Excel Tech., Ltd. (XLTEK) is recalling the Natus Brain Monitor Breakout Box due to labeling errors. The hazard involves left side labeling showing impedance for the right side.
How to tell if you have it
Brand: Natus
Product: Natus Brain Monitor Breakout Box; full-montage standard electroencephalograph
According to the FDA, Natus received two complaints of left side labeling showing impedance for the right side.
Context
GovInfoNow's records show Natus Neurology DBA Excel Tech., Ltd. (XLTEK) has 5 other recalls on record since 2018-05-15. Other recent recalls of similar products include Natus OBM DAB Digital Acquisition Box: Backward Electrode Labels Risk Misdiagnosis in Neonates (2025-05-07), Natus Neurology IPELA FHD PTZ Tile Kits Recall: Ceiling Tile Risk (2021-12-02), and Natus Olympic Brainz Monitor Recall: Unverified System Functionality (2020-03-05). Other recent recalls of similar products include Spacelabs Healthcare Multi-parameter Command Module Model 91496 Recall: Inaccurate Cardiac Output Readings (2026-02-27).
How to tell if you have this one
Check for the part number 021911 and serial numbers listed in the recall notice. The device is a full-montage standard electroencephalograph used in medical monitoring.
Brand
Natus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Labeling
Verify if the left side of the device shows impedance readings for the right side.
Where it went and when
Where it was distributed
Distributed in 7 states.
Listed by the agency
Not listed
FDA distribution: “US: CA, IN, MO, NC, PA, RI, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Indiana, Missouri, North Carolina, Pennsylvania, Rhode Island, Texas.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2138-2025 (June 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2138-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.