Class II U.S. Food and Drug Administration

Axonics, Inc. PNE Lead Implant Kit REF: 1701 recall: Retroactively Reported: 10mL luer lock syringes included in kit may leak

Recall published 5 days ago

Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0198-2027
Published
October 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Axonics, Inc.
Product type
Medical devices
Units affected
18,294 kits
Distribution
Nationwide
Made in
United States
Lot / code info
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 AK1A831002 AK1A831004 AK1A831005 AK1A831006 AK1A831007 AK1A831008 AK1A831012 AK1A931006 AK1A931007 AK1A931008 AK1A931009 AK1A931010 AK1A931011 AK1A931012 AK1A931013 AK1A931014 AK1A931015 AK1AC31001 AK1AC31002 AK1AC31003 AK1AC31004 AK1AC31005 AK1A831003 AK1A831009 AK1A831010 AK1A831011 AK1A831012 AK1A831013 AK1A931015 AK1A931016 AK1A931017 AK1A931018 AK1A931019 AK1AA31001 AK1AA31002 AK1AA31003 AK1AA31004 AK1AA31005 AK1AA31006 AK1AA31007 AK1AA31008 AK1AA31009 AK1AA31010 AK1AA31011 AK1AA31012 AK1AA31013 AK1AA31014 AK1AA31015 AK1AA31016 AK1AA31017 AK1AA31018 AK1AA31019 AK1AA31020 AK1AA31021 AK1AB31001 AK1AB31002 AK1AB31003 AK1AB31004 AK1AB31005 AK1AB31006 AK1AB31007 AK1AB31008 AK1AB31009 AK1AB31010 AK1LB31001 AK1LB31002 AK1AB31011 AK1AB31012 AK1AB31013 AK1AB31014 AK1AB31015 AK1LB31003 AK1AC31001 AK1AC31005 AK1AC31006 AK1AC31007 AK1AC31008 AK1AC31009 AK1AC31010 AK1AC31011 AK1AC31012 AK1AC31013 AK1AC31014 AK1AC31015 AK1AC31016 AK1AC31017 AK1AC31018 AK1AC31019 AK1A141001 AK1A141002 AK1A141003 AK1A141004 AK1A141005 AK1A141006 AK1A141007 AK1A141009 AK1A141023 AK1A141024 AK1A141025 AK1A141026 AK1A141027 AK1A241000 AK1A241002 AK1A241003 AK1A241004 AK1A241005 AK1A241006 AK1A241008 AK1A831014 AK1A831015 AK1A831016 AK1A831017 AK1A831018 AK1A831019 AK1A831020 AK1A931001 AK1A931002 AK1A931003 AK1A931004 AK1A931005 AK1AA31001 AK1A141008 AK1A141010 AK1A141011 AK1A141012 AK1A141013 AK1A141014 AK1A141015 AK1A141016 AK1A141017 AK1A141018 AK1A141019 AK1A141020 AK1A141021 AK1A141022 AK1A141023 AK1A341001 AK1A341002 AK1A341003 AK1A341004 AK1A341005 AK1A241006 AK1A241007 AK1A241008 AK1A241009 AK1A241010 AK1A241011 AK1A241012 AK1A241013 AK1A241014 AK1A241015 AK1A241016 AK1A241017 AK1A241018 AK1A241019 AK1A241020 AK1A241021 AK1A241022 AK1A241023 AK1A241024 AK1A241025 AK1A241026 AK1A341005 AK1A341006 AK1A341007 AK1A341008 AK1A341009 AK1C341021 AK1C341022 AK1C441003 AK1C441004 AK1C441005 AK1C441006 AK1C441007 AK1C441009 AK1D441010 AK1Z531001 AK1Z531002 AK1Z531003 AK1Z531004 AK1Z531005 AK1Z531006
UPC codes
10810005340134

Products covered by this recall

PNE Lead Implant Kit REF: 1701

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10810005340134

Model or item number

On the rating label, the box or the instruction sheet.

  • 1701

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Axonics, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Axonics, Inc. — 26 Technology Dr, Irvine, CA, 92618-2380

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Axonics, Inc. medical devices recalled?

Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users. Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10810005340134; model number 1701. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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