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Use caution Medical device recall · FDA · Published July 16, 2021

Philips HeartStart Infant/Child Smart Pads Cartridge Recall: Incorrect Labeling Risk

Philips recalls infant/child defibrillator pads with incorrect labeling that may delay therapy or deliver lower energy than needed for adult patients. Affected pads are for children under 8 years and less than 55 lbs.

🇺🇸 FDA recall #Z-2427-2021Medical devicePhilips ›
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Recalling firmPhilips North America LLC22100 Bothell Everett Hwy · Bothell, WA 98021-8431
✎ GovInfoNow plain-language explainer

Philips is recalling infant and child defibrillator pads that have incorrect labeling. This could cause delays in life-saving therapy or deliver less energy than needed for an adult patient. The recall affects pads for children under 8 years and less than 55 pounds. Read more at govinfonow.com/recall/62200-philips-heartstart-infant-child-smart-pads-cartridge-recall-incorrect-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/62200-philips-heartstart-infant-child-smart-pads-cartridge-recall-incorrect-labeling · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2427-2021

Cite this page

“Philips HeartStart Infant/Child Smart Pads Cartridge Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62200-philips-heartstart-infant-child-smart-pads-cartridge-recall-incorrect-labeling. Based on FDA recall #Z-2427-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2427-2021%22&limit=1).

The FDA announced on July 16, 2021, that Philips North America LLC is recalling Infant/Child defibrillator pads due to incorrect labeling. This error could lead to delayed therapy or delivery of lower energy than indicated for an adult patient.

How to tell if you have it

  • Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123
  • Lot Y111220-01
  • UPC 00884838023758

The hazard

The infant/child defibrillator pads contain incorrect labeling. According to the FDA, this could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient.

Context

GovInfoNow's records show Philips North America Llc has 129 other recalls on record since July 12, 2017. Other recent recalls include the SmartPath to dStream recall (Aug. 21, 2026), the Spectral CT 7500 Scanner recall (Aug. 18, 2026), and the Brilliance CT 64 Medical Scanner recall (Aug. 7, 2026). Other recent recalls of similar products include the Physio-Control Infant/Child Defibrillator Electrodes Recall (Jan. 21, 2026) and the Medtronic MiniMed 780G Insulin Pump Recall (July 13, 2026).

How to tell if you have this one

Check for the model number M5072A on the cartridge. The product is for children under 8 years and less than 55 pounds (25 kg). The lot number Y111220-01 is associated with this recall.

  • Brand
    Philips
  • Product
    Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the model number M5072A and lot number Y111220-01 on the cartridge.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

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: “Worldwide distribution. US Nationwide, Australia, Austria, Bolivia, Canada, Chile, China, Denmark, France, French Polynesia, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Republic of Korea, Malta, Martinique, Mexico, Monaco,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

1. Firm started the recall: Jul 16, 202112. FDA classified it Class II: Sep 3, 202123. Published in FDA’s Enforcement Report: Sep 15, 202134. FDA terminated the recall: May 12, 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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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-2427-2021 (July 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2427-2021 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