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Use caution Medical device recall · FDA · Published June 9, 2021

Cardinal Health Infant Heel Warmer Recall: Risk of Splash Injury During Activation

Cardinal Health recalls infant heel warmers with potential splash risk during activation. Contact may cause rash, burns, or inflammation. Learn if your product is affected and what to do.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2094-2021Medical deviceCardinal Health ›
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Contact the company

Recalling firmCardinal Health 200, LLC15 Hampshire St Bldg 5 · Mansfield, MA 02048-1113
✎ GovInfoNow plain-language explainer

Cardinal Health is recalling infant heel warmers that could splash liquid during activation, potentially causing burns or rashes on the infant's skin. This risk occurs when the warmer is activated too close to the infant's face or body. Read more at govinfonow.com/recall/62362-cardinal-health-infant-heel-warmer-recall-risk-of-splash-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/62362-cardinal-health-infant-heel-warmer-recall-risk-of-splash-injury · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2094-2021

Cite this page

“Cardinal Health Infant Heel Warmer Recall: Risk of Splash Injury During Activation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62362-cardinal-health-infant-heel-warmer-recall-risk-of-splash-injury. Based on FDA recall #Z-2094-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2094-2021%22&limit=1).

Cardinal Health 200, LLC voluntarily recalled the Infant Heel Warmer with Attachment Tab (SKU MH00002T) on June 9, 2021, according to the FDA. The agency announced the Class II recall due to a hazard where activated pouches may rupture or leak, potentially causing rash, burns, or inflammation if contents splash into eyes or onto an infant.

How to tell if you have it

  • Brand: Cardinal Health
  • Product: Infant Heel Warmer with Attachment Tab, Nonsterile
  • SKU: MH00002T

The hazard

The recall addresses reports of packs rupturing or leaking during activation, which may result in contents splashing into the user's eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch include rash, burn, and inflammation.

Context

GovInfoNow's records show Cardinal Health 200, LLC has 59 other recalls on record since June 27, 2017. Other recent recalls of similar products include Presource Packs with Microstream Components Risk of Delayed Treatment (Aug. 19, 2026), Cardinal Health 200, LLC recalls Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets (Aug. 18, 2026), Cardinal Health Presource Convenience Kits Recall: Contaminated Applicators Risk Infection (Aug. 10, 2026), and ICU Medical Hotline Fluid Warming Set Recall: Leakage Risk in Specific Lots (June 24, 2026).

How to tell if you have this one

The product is labeled 'Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T'. It was sold as an active product for blood draws at the point of care.

  • Brand
    Cardinal Health
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA ,ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.
Recall numberProduct, codes & lotsQuantity
Z-2094-2021Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws; All lots926,425 units
Z-2095-2021Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws; All lots2,911,064 units
Based on the official FDA remedy

What to do — step by step

  1. Check Activation Distance

    Ensure the warmer is activated at least 6 inches away from the infant's face and body to prevent splashes.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 46 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA ,ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Jun 9, 202112. FDA classified it Class II: Jul 19, 202123. Published in FDA’s Enforcement Report: Jul 28, 202134. FDA terminated the recall: Nov 1, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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Keep exploring

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-2094-2021 (June 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2094-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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