# Class II recall Z-0198-2027: Axonics, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0198-2027 |
| Recalling firm | Axonics, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | PNE Lead Implant Kit  REF: 1701 |
| Reason | Retroactively Reported: 10mL luer lock syringes included in kit may  leak , break or experience  other issues that may pose a risk to users. |
| Quantity | 18,294 kits |
| Distribution | US Nationwide distribution including in the states of FL, AL, NE, CA, NY,MI, SC, IL, NC, KY, VA, CO, KS, AZ, OH, MN, PA, ND, MD, OK, GA, AR, WI, TX, SD, CT, IN, LA, WA, OR, WV, MA, TN, MT, NJ, DE, ME, NM, IA, NH, MO, NV, MS, DC, ID, VT, WY, UT and the countries of United Kingdom & Australia. |
| Recall initiated | 2024-07-15 |
| Reported | 2026-10-28 |
| Firm location | Irvine, CA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 8 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0198-2027%22). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.