Neurostimulation Kit — Class II medical device recall Z-2257-2024
Ongoing recall by Nalu Medical, Inc., reported 2024-07-10, distributed nationwide. Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequ
| Recall number | Z-2257-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nalu Medical, Inc., Carlsbad, CA, United States |
| Recall initiated | 2024-06-03 |
| Classified | 2024-07-03 |
| Reported by FDA | 2024-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 13 |
| UPC / GTIN / UDI-DI | 00812537030524, 00812537030975, 00812537033518, 00812537033600, 00812537035598, 00812537035604, 00812537036137, 00812537036441 |
| Serial numbers | H01373, H01377, H01378, H01382, H01387, H01415, H01419, H01428, H01431, H01432, H01438, H01441, H01445 |
| Model numbers | 71005-US, 71019-US |
Product
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
Reason for recall
Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.
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-2257-2024. 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.