Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported June 18, 2025
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No
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 thi…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Natus Neurology DBA Excel Tech., Ltd. (Xltek) recalled Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (D… - a moderate-severity action.
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (D… was recalled by Natus Neurology DBA Excel Tech., Ltd. (Xltek) in June 18, 2025. Reason: Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately l…. Check the official notice for the remedy. Verify recall #Z-1925-2025 with the FDA Devices before acting.
The recall
Natus Neurology DBA Excel Tech., Ltd. (Xltek) issued this moderate-severity FDA Devices recall-Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately l….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- June 18, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1925-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1925-2025) was formally reported on June 18, 2025, with the manufacturer initiating the action on May 7, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Natus Neurology DBA Excel Tech., Ltd. (Xltek) is listed as the recalling firm, operating out of Oakville. Federal records list the affected scope as 3069.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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), Colombi…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3069
Related Recalls
6
3 from same agency
Product description
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1925-2025 |
| Date reported | June 18, 2025 |
| Date initiated | May 7, 2025 |
| Recalling firm | Natus Neurology DBA Excel Tech., Ltd. (Xltek) |
| Firm location | Oakville |
| Affected scope | 3069 |
| 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 … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1925-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No. Recalled by Natus Neurology DBA Excel Tech., Ltd. (Xltek). Units affected: 3069.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2025. Severity: Moderate. Recall number: Z-1925-2025.
Where was the recalled product distributed? ▼
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 (the) (NL), Japan (JP), United Kingdom of Great Britain and Northern Ireland(the) (GB), Russian Federation (the)(RU), Bolivia (Plurinational State of) (BO), Canada (CA), France (FR), Peru (PE), Guyana (GY), Mexico (MX), Belgium (BE), Thailand (TH), Paraguay (PY), Hong Kong (HK), United Arab Emirates (AE), Austria (AT), India (IN), Indonesia (ID), Kuwait (KW), Qatar (QA), Lithuania (LT), Denmark (DK), Myanmar (MM), Uruguay (UY), Tunisia (TN), Turkey (TR), Korea (the Republic of) (KR), Hungary (HU), Slovenia (SI), Argentina (AR), Norway (NO), Oman (OM), Poland (PL), Finland (FI), Ireland (IE), Australia (AU), Latvia (LV), Ecuador (EC), Singapore (SG), Spain (ES), Serbia (RS), South Africa (ZA), Romania (RO), Algeria (DZ), Portugal (PT), Dominican Republic (the) (DO), Lebanon (LB), Malaysia (MY), Costa Rica (CR), Viet Nam (VN), & Bahrain (BH)..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1925-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 18, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.