Moberg Component Neuromonitoring System — Class II medical device recall Z-1338-2023
Ongoing recall by Moberg Research, Inc., reported 2023-04-12, distributed nationwide. Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to
| Recall number | Z-1338-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Moberg Research, Inc., Ambler, PA, United States |
| Recall initiated | 2023-02-20 |
| Classified | 2023-04-04 |
| Reported by FDA | 2023-04-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, FR, IT, SE |
| Quantity | 89 units |
| Reason classes | packaging |
| Serial numbers | A-CNS-22502, A-CNS-22506, A-CNS-22507, A-CNS-22508, A-CNS-22509, A-CNS-22510, A-CNS-22511, A-CNS-22512, A-CNS-22513, A-CNS-22525, A-CNS-22526, A-CNS-22527, A-CNS-22528, A-CNS-22529, A-CNS-22530, A-CNS-22534, A-CNS-22535, A-CNS-22536, A-CNS-22537, A-CNS-22541, A-CNS-22542, A-CNS-22543, A-CNS-22544, A-CNS-22545, A-CNS-22546 and 38 more |
| Model numbers | CNS-350 |
Product
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350
Reason for recall
Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC
Machine access
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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.