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Lower risk Medical device recall · FDA · Published June 16, 2023

NovaPlus Infant Heel Warmer Recall: Burst/Leaking Risk

Cardinal Health recalls NovaPlus Infant Heel Warmers with tape due to burst or leaking complaints reported from mid-April to May. Affected units have specific catalog and lot numbers.

🇺🇸 FDA recall #Z-2147-2023Medical deviceCardinal Health ›
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Recalling firmCardinal Health 200, LLC3651 Birchwood Dr · Waukegan, IL 60085-8337
✎ GovInfoNow plain-language explainer

What happened, in plain English

Cardinal Health is recalling NovaPlus Infant Heel Warmers with tape after receiving reports of burst or leaking issues from mid-April to May. This could pose a risk to infants if the warmer leaks or bursts. Read more at govinfonow.com/recall/57834-novaplus-infant-heel-warmer-recall-burst-leaking-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57834-novaplus-infant-heel-warmer-recall-burst-leaking-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2147-2023

Cite this page

“NovaPlus Infant Heel Warmer Recall: Burst/Leaking Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/57834-novaplus-infant-heel-warmer-recall-burst-leaking-risk. Based on FDA recall #Z-2147-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2147-2023%22&limit=1).

Why it’s dangerous

The warmer has been reported to burst or leak, which could cause harm to infants if the warmer leaks or bursts. This issue was noticed in the period from mid-April to May.

Who’s affected

Parents or caregivers who purchased the NovaPlus Infant Heel Warmer with tape (catalog number V1146:010) between mid-April and May are likely affected. Infants using the warmer are at the highest risk.

How to tell if you have this one

Check for the catalog number V11460-010 and lot number V2S056 on the product packaging. The warmer uses tape and is designed for infant heel warming.

  • Brand
    Cardinal Health
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the catalog number V11460-010 and lot number V2S056 on the product packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 40 days after the firm started it.

1. Firm started the recall: Jun 16, 202312. FDA classified it Class II: Jul 17, 202323. Published in FDA’s Enforcement Report: Jul 26, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2147-2023 (June 16, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2147-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA