CLASS II ONGOING Device recall · Reported 3 Apr 2024 · FDA Enforcement Report

Neonatal ArcticGel Pads recalled by Medivance

Medivance is recalling Medivance Neonatal ArcticGel Pads, distributed nationwide in the US. The recall was initiated on 16 Feb 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF/UDI-DI/Lot(Expiration Date): 31802/00801741132131/NGGX5390(31Oct2024), NGGX1179(31Oct2024), NGGX1156(31Oct2024), NGHP2415(28Feb2025), NGHP2411(28Feb2025), NGHT1139(31May2025), NGHTY603(31May2025), NGHV4383(31Jul2025), NGHW1507(31Aug2025); 3180202/10801741132138/NGGZ2622(31Dec2024), NGGV1829(31Aug2024), NGGW3254(30Sep2024), NGHQ2940(31Mar2025); 31802C/00801741223457/NGGV1784(31Aug2024)

Quantity recalled1,654

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1381-2024
FDA event ID: 94030
Recalling firm: Medivance, Louisville, CO
Classification: Class II
Status: Ongoing
Recall initiated: 16 Feb 2024
FDA classified: 26 Mar 2024
Reported: 3 Apr 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

16 Feb 2024	Recall initiated by company
26 Mar 2024	Classified by FDA	+39 days
3 Apr 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

Where it was distributed

Worldwide - US Nationwide distribution including in the states of IL, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Australia, Singapore, South Korea, Taiwan, Japan, China, Thailand.

Nationwide Alabama Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota

Questions about this recall

Is Neonatal ArcticGel Pads recalled?

Yes. Medivance recalled Neonatal ArcticGel Pads on 16 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1381-2024.

Why was it recalled?

Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.

Which lots are affected?

REF/UDI-DI/Lot(Expiration Date): 31802/00801741132131/NGGX5390(31Oct2024), NGGX1179(31Oct2024), NGGX1156(31Oct2024), NGHP2415(28Feb2025), NGHP2411(28Feb2025), NGHT1139(31May2025), NGHTY603(31May2025), NGHV4383(31Jul2025), NGHW1507(31Aug2025); 3180202/10801741132138/NGGZ2622(31Dec2024), NGGV1829(31Aug2024), NGGW3254(30Sep2024), NGHQ2940(31Mar2025); 31802C/00801741223457/NGGV1784(31Aug2024)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Reported	Class	Recall	Company	Reason	Where
7 Aug 2024Device	CLASS II	Arctic Sun Temperature Management Systems, Name recalled by Medivance	Medivance	Lead & Heavy Metals	Nationwide

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