Physio-Control recalls infant/child defibrillator electrodes with delamination risk. These electrodes may cause injury during emergency use. Affected units have specific catalog numbers and lot numbers.
Due to pediatric defibrillator electrode delamination
Physio-Control is recalling infant and child reduced energy defibrillator electrodes due to a risk of delamination. This could lead to improper defibrillation during emergencies, potentially causing serious injury to children under 8 or weighing less than 25kg.
The electrodes can delaminate, meaning the layers separate during use. This could cause improper energy delivery during a cardiac emergency, potentially leading to ineffective defibrillation and serious injury to the child.
Parents and caregivers of children under 8 years old or weighing less than 25kg (55lbs) who use these electrodes with a defibrillator. Emergency medical personnel trained in basic life support may also be affected.
Check for catalog numbers 11101-000016 or 11101-000017. Look for UDI-DI codes 00721902629013 or 00721902682483. Affected units were sold with lot numbers 315303, 315639, 315858, 316007, 320529, or 318931.
Identify your electrodes using the catalog numbers or UDI-DI codes listed in the recall notice.
Reach out to Physio-Control for guidance on next steps if you have affected electrodes.
The electrodes may delaminate, which could lead to improper defibrillation during an emergency, potentially causing serious injury to children.
Parents and caregivers of children under 8 years old or weighing less than 25kg (55lbs) who use these electrodes with a defibrillator.
Check for catalog numbers 11101-000016 or 11101-000017, UDI-DI codes 00721902629013 or 00721902682483, or lot numbers 315303, 315639, 315858, 316007, 320529, or 318931.
We’ve drafted a message you can send Physio-Control to request your refund or repair — edit it as you like.
Subject: Recall Z-1544-2026 — Physio-Control Physio-Control Hello, I own a Physio-Control that is covered by recall Z-1544-2026 from Physio-Control. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.