Physio-Control Infant/Child Defibrillator Electrodes Recall: Pediatric Electrode
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.
Use caution until it’s fixed
Due to pediatric defibrillator electrode delamination
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/50120-physio-control-infant-child-defibrillator-electrodes-recall-pediatric-electrode-delamination.
Source Summary by GovInfoNow · govinfonow.com/recall/50120-physio-control-infant-child-defibrillator-electrodes-recall-pediatric-electrode-delamination · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1544-2026
Cite this page
“Physio-Control Infant/Child Defibrillator Electrodes Recall: Pediatric Electrode.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50120-physio-control-infant-child-defibrillator-electrodes-recall-pediatric-electrode-delamination. Based on FDA recall #Z-1544-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1544-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Physio-Control- Category
Medical device
What to do — step by step
Check Electrode Details
Identify your electrodes using the catalog numbers or UDI-DI codes listed in the recall notice.
Contact Manufacturer
Reach out to Physio-Control for guidance on next steps if you have affected electrodes.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 48 states.
FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, 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, OR, PA, RI, SC, SD, TN, TX, UT,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, 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, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-1544-2026 (January 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1544-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.