Axonics, Inc. recalls PNE Lead Implant Kit REF: 1701
- Recalling company
- Axonics, Inc.
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 15, 2024
- Reported
- Oct 28, 2026
- 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.
- Status
- Ongoing
- Quantity
- 18,294 kits
- Lot / codes
- 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
- Company location
- Irvine, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0198-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0198-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.