Reported Oct 28, 2026 · Ongoing · Updated Nov 2, 2026
PNE Lead Implant Kit REF: 1701
Axonics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Axonics, Inc. · 26 Technology Dr · Irvine, CA · 92618-2380
Is this the product you have?
- PNE Lead Implant Kit REF1701
- Lot codes and dates
- UDI10810005340134/
- Lots
234 of 234 codes
AK1Z531006AK1Z531009AK1Z531010AK1Z531011AK1Z531012AK1Z531013AK1Z531014AK1Z531007AK1Z531008AK1Z531015AK1Z531016AK1Z531017AK1Z531018AK1Z531019AK1Z631001AK1Z631002AK1Z631003AK1Z631006AK1Z631007AK1Z631008AK1Z631009AK1Z731001AK1Z731002AK1Z631004AK1Z631005AK1Z731002AK1Z731003AK1Z731004AK1Z731005AK1Z731006AK1Z731007AK1Z731008AK1Z731008AK1Z731009AK1Z731010AK1Z731011AK1Z731012AK1Z731013AK1Z731014AK1Z731015AK1Z731016AK1A731017AK1A731018AK1A731019AK1A731019AK1A731020AK1A731021AK1A731022AK1A731023AK1A731024AK1A731025AK1A831001AK1A831002AK1A831004AK1A831005AK1A831006AK1A831007AK1A831008AK1A831012AK1A931006
- Amount recalled
- 18,294 kits
Where it was sold
Why it was recalled
Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.
This product could cause temporary or reversible health problems — stop using it.
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