Medivance Inc.: Medical Device Recall in 2024 - (Recall #: Z-1381-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 16, 2024

Date Posted: April 3, 2024

Recall Number: Z-1381-2024

Event ID: 94030

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.

Status: Ongoing

Product Quantity: 1,654

Code Information:

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)

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated