Brand Name: OBM00002 OBM DAB — Class II medical device recall Z-1925-2025
Ongoing recall by Natus Neurology DBA Excel Tech., Ltd. (XLTEK), reported 2025-06-18, distributed nationwide. Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately le
| Recall number | Z-1925-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Neurology DBA Excel Tech., Ltd. (XLTEK), Oakville, Canada |
| Recall initiated | 2025-05-07 |
| Classified | 2025-06-09 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BO, CA, CH, CL, CN, CO, CR, DE, DK, DO, DZ, EC, EE, ES, FI, FR, GB, GY, HK, HU, ID, IE, IL, IN, IT, JP, KR, KW, LB, LT, LV, MX, MY, NL, NO, OM, PE, PL, PT, PY, QA, RO, RS, SA, SG, SI, TH, TN, TR, UY, VN, ZA |
| Quantity | 3,069 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00382830010825 |
| Serial numbers | 001 |
| Model numbers | OBM00002OBM |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1925-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.