Lower riskMedical device recall · FDA · Published May 7, 2025
Natus OBM DAB Digital Acquisition Box: Backward Electrode Labels Risk Misdiagnosis
Natus recalls OBM DAB digital acquisition boxes with backward electrode labels that could cause misdiagnosis of neonatal seizures. Affected units have serial numbers starting with OBM. Contact Natus for details.
Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
Natus is recalling digital acquisition boxes used for neonatal seizure monitoring because electrode labels were applied backwards. This could lead to misdiagnosis of seizure locations in newborns. The recall affects specific model units with serial numbers starting with OBM. Read more at govinfonow.com/recall/52328-natus-obm-dab-digital-acquisition-box-backward-electrode-labels-risk.
“Natus OBM DAB Digital Acquisition Box: Backward Electrode Labels Risk Misdiagnosis.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52328-natus-obm-dab-digital-acquisition-box-backward-electrode-labels-risk. Based on FDA recall #Z-1925-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1925-2025%22&limit=1).
The FDA announced on May 7, 2025, that Natus Neurology DBA Excel Tech., Ltd. (XLTEK) is recalling the OBM00002 OBM DAB (Digital Acquisition Box). The agency stated the recall addresses electrode placement labels applied backwards, which may lead to misdiagnosis of seizure location in neonates.
How to tell if you have it
Brand: Natus Neurology
Product Name: OBM00002 OBM DAB (Digital Acquisition Box)
Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box)
Serial Numbers 001 through OBM00002H3613
Units affected: 3069
The hazard
The electrode placement labels on the Digital Acquisition Box were applied backwards. This error may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
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 Brain Monitor Breakout Box Recall (2025-06-18), Natus Neurology IPELA FHD PTZ Tile Kits Recall (2021-12-02), and Natus Olympic Brainz Monitor Recall (2020-03-05). Other recent recalls of similar products include Canon Vantage Galan 3T Medical Device Recall (2025-10-16), Nova Biomedical StatStrip Glucose Meter System Recall (2026-07-29), and GEM Premier 5000 Blood Analyzer (2026-05-08).
How to tell if you have this one
Check the serial number on your OBM DAB device. Affected units have serial numbers starting with 'OBM' followed by a sequence of numbers (e.g., OBM00002H3613).
Brand
Natus Neurology
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Look for a serial number starting with 'OBM' on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide including Puerto Rico (PR) and OUS (foreign) countries of: Italy (IT), Estonia (EE), Israel (IL), China (CN), Germany (DE), Saudi Arabia (SA), Switzerland (CH), Chile (CL), Colombia (CO), Netherlands…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
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-1925-2025 (May 7, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1925-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.