# FDA recall Z-2257-2024

> **Nalu Medical, Inc.** · Class II · device recall initiated 2024-06-03.

## 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.

## Distribution

US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.

## Key facts

- **Recall number:** Z-2257-2024
- **Recalling firm:** Nalu Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-03
- **Report date:** 2024-07-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2257-2024

## Citation

> AI Analytics. FDA recall Z-2257-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2257-2024. Source: US FDA. Licensed CC0.

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