Class II U.S. Food and Drug Administration

Physio-Control, Inc. Physio Control Infant/Child Reduced Energy Defibrillator recall: Due to pediatric defibrillator electrode delamination

Recall published 7 months ago

Due to pediatric defibrillator electrode delamination

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Due to pediatric defibrillator electrode delamination

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1544-2026
Published
March 18, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Physio-Control, Inc.
Product type
Medical devices
Units affected
16,499 electrodes (US/OUS: 8327/8172)
Distribution
Nationwide
Made in
United States
Lot / code info
Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Lot Numbers: 315303, 315639, 315858, 316007, 320529, 318931
UPC codes
00721902629013, 00721902682483

Products covered by this recall

PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).

Check your product

The notice names 11 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00721902629013
  • 00721902682483

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 315303
  • 315639
  • 315858
  • 316007
  • 320529
  • 318931 — 16
  • 499 electrodes

Package size

Match the net weight or the piece count on the front of the pack.

  • 25 kg
  • 55 lbs

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Physio-Control, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Physio-Control, Inc. — 11811 Willows Rd Ne, Redmond, WA, 98052-2003

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Physio-Control, Inc. medical devices recalled?

Due to pediatric defibrillator electrode delamination Due to pediatric defibrillator electrode delamination

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00721902629013, 00721902682483; lot code 315303, 315639, 315858. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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