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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Medivance Inc.: Neonatal ArcticGel Pads Recalled for Reduced Water Flow and Cooling Failure

Agency Publication Date: March 26, 2024
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Summary

Medivance is recalling 1,654 units of Neonatal ArcticGel Pads used in temperature management systems. These pads are experiencing reduced water flow, which can prevent the system from properly heating or cooling a newborn patient. This defect can lead to ineffective temperature regulation during critical medical procedures. Consumers and healthcare providers should check their inventory for specific reference and lot numbers and contact the manufacturer for further instructions.

Risk

Reduced water flow within the pads prevents the temperature management system from maintaining the correct body temperature for the infant. This failure can result in the patient becoming too hot or too cold, potentially leading to serious health complications for vulnerable neonates.

What You Should Do

  1. Check your medical inventory for Medivance Neonatal ArcticGel Pads with Reference numbers 31802, 3180202, or 31802C.
  2. Verify if your pads match the following lot numbers and expiration dates: For REF 31802, check for lots NGGX5390 (31Oct2024), NGGX1179 (31Oct2024), NGGX1156 (31Oct2024), NGHP2415 (28Feb2025), NGHP2411 (28Feb2025), NGHT1139 (31May2025), NGHTY603 (31May2025), NGHV4383 (31Jul2025), or NGHW1507 (31Aug2025).
  3. For REF 3180202, check for lots NGGZ2622 (31Dec2024), NGGV1829 (31Aug2024), NGGW3254 (30Sep2024), or NGHQ2940 (31Mar2025).
  4. For REF 31802C, check for lot NGGV1784 (31Aug2024).
  5. Contact your healthcare provider or Medivance Inc. at 1-888-463-6332 for further instructions regarding the use or return of these affected pads and to discuss potential remedies.
  6. For additional questions or to report issues, contact the FDA's medical device recall line at 1-888-INFO-FDA (1-888-463-6332).

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medivance Neonatal ArcticGel Pads (REF: 31802)
Model / REF:
31802
UPC Codes:
00801741132131
Lot Numbers:
NGGX5390 (Exp 31Oct2024)
NGGX1179 (Exp 31Oct2024)
NGGX1156 (Exp 31Oct2024)
NGHP2415 (Exp 28Feb2025)
NGHP2411 (Exp 28Feb2025)
NGHT1139 (Exp 31May2025)
NGHTY603 (Exp 31May2025)
NGHV4383 (Exp 31Jul2025)
NGHW1507 (Exp 31Aug2025)
Product: Medivance Neonatal ArcticGel Pads (REF: 3180202)
Model / REF:
3180202
UPC Codes:
10801741132138
Lot Numbers:
NGGZ2622 (Exp 31Dec2024)
NGGV1829 (Exp 31Aug2024)
NGGW3254 (Exp 30Sep2024)
NGHQ2940 (Exp 31Mar2025)
Product: Medivance Neonatal ArcticGel Pads (REF: 31802C)
Model / REF:
31802C
UPC Codes:
00801741223457
Lot Numbers:
NGGV1784 (Exp 31Aug2024)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94030
Status: Active
Manufacturer: Medivance Inc.
Sold By: Direct distribution to hospitals and medical facilities
Manufactured In: United States
Units Affected: 1,654
Distributed To: Illinois, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.