Medivance Inc. Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Brand
Medivance Inc.
Lot Codes / Batch Numbers
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)
Products Sold
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)
Medivance Inc. is recalling Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C due to 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 te. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 2/16/24, BD mailed or emailed recall notices to customers who were asked to do the following: 1) Immediately Discontinue Use 2) Immediately quarantine affected pads, record your inventory totals on the Customer Response Form, discard all devices within your facility's control per your facility's procedures. 3) Share this notice with any users of the product within your facilities or with any facility affected product was distributed to. 4) Complete and return the attached Customer Response Form to the BD contact noted on the form. If you require further assistance contact BD Customer Support at 1-844-823-5433. Say "Recall" when prompted M-F 8am -5pm CT.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026