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Class IIOngoing

Axonics, Inc. recalls PNE Lead Implant Kit REF: 1701

Recall date · record updated Oct 28, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Axonics, Inc.
Reason
Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99907…

Products

  1. PNE Lead Implant Kit REF: 1701

    Codes/lots: UDI: 10810005340134/ Lots: AK1Z531006 AK1Z531009 AK1Z531010 AK1Z531011 AK1Z531012 AK1Z531013 AK1Z531014 AK1Z531007 AK1Z531008 AK1Z531015 AK1Z531016 AK1Z531017 AK1Z531018 AK1Z531019 AK1Z631001 AK1Z631002 AK1Z631003 AK1Z631006 AK1Z631007 AK1Z631008 AK1Z631009 AK1Z731001 AK1Z731002 AK1Z631004 AK1Z631005 AK1Z731002 AK1Z731003 AK1Z731004 AK1Z731005 AK1Z731006 AK1Z731007 AK1Z731008 AK1Z731008 AK1Z731009 AK1Z731010 AK1Z731011 AK1Z731012 AK1Z731013 AK1Z731014 AK1Z731015 AK1Z731016 AK1A731017 AK1A731018 AK1A731019 AK1A731019 AK1A731020 AK1A731021 AK1A731022 AK1A731023 AK1A731024 AK1A731025 AK1A831001 AQuantity: 18,294 kitsRecall no. Z-0198-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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