PNE Lead Implant Kit
Medical device recall Z-0198-2027. Published in FDA’s Enforcement Report on Oct 28, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 28, 2026. Copied from openFDA on Nov 4, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 48 states named
- 18,294 kits how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Which ones are recalled?
PNE Lead Implant Kit REF: 1701
18,294 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Codes to check against yours
UDI: 10810005340134/ Lots: AK1Z531006 AK1Z531009 AK1Z531010 AK1Z531011 AK1Z531012 AK1Z531013 AK1Z531014 AK1Z531007 AK1Z531008 AK1Z531015 AK1Z531016 AK1Z531017 AK1Z531018 AK1Z531019 AK1Z631001 AK1Z631002 AK1Z631003 AK1Z631006 AK1Z631007…
Every code shown here, 1,996 characters
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…
FDA’s list runs to 2,600 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
48 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 15, 2024.
- FDA classified it on Oct 16, 2026.
- FDA’s Enforcement Report published it on Oct 28, 2026.
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Who is recalling it?
- Axonics, Inc., of Irvine, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,600 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Nov 3, 2026 and checked Nov 4, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Nov 4, 2026.