Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Natus Brain Monitor Breakout Boxes Recalled for Incorrect Labeling

Agency Publication Date: July 18, 2025
Share:
Sign in to monitor this recall

Summary

Natus Neurology is recalling 27 units of the Natus Brain Monitor Breakout Box (Part Number 021911), which is a device used for electroencephalograph (EEG) monitoring. The recall was issued because the left-side labels on the device incorrectly show impedance readings for the right side. Natus received two complaints regarding this labeling error before initiating the voluntary recall via letter to affected customers.

Risk

Incorrect labeling of impedance values can lead to confusion or technical errors during neurological monitoring. If a clinician relies on these mislabeled readings, it could result in improper setup or difficulty interpreting the patient's brain activity data accurately.

What You Should Do

  1. This recall affects Natus Brain Monitor Breakout Boxes with Part Number 021911 and UDI/DI 038283NA00153ED.
  2. Check the serial number on your device to determine if it is one of the 27 affected units. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer, Natus Neurology, or your distributor to arrange for a return, replacement, or correction of the device.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or to report any adverse events.

Your Remedy Options

๐Ÿ“‹Other Action

Corrective action or return

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Natus Brain Monitor Breakout Box
Model / REF:
021911
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
UDI:
038283NA00153ED

Full-montage standard electroencephalograph.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97091
Status: Active
Manufacturer: Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Sold By: Authorized medical device distributors
Manufactured In: Canada
Units Affected: 27 units
Distributed To: California, Indiana, Missouri, North Carolina, Pennsylvania, Rhode Island, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.