FDA recall, , Moderate risk
Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes
Infant/Child Reduced Energy Defibrillator Electrodes may delaminate, which can affect defibrillation.
Summary by Recall Canary from the FDA notice
What happened
Physio-Control, Inc., of Redmond, Washington, is recalling PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes due to pediatric defibrillator electrode delamination.
The recall, which began January 21, 2026, was added to the FDA's Enforcement Report on March 10, 2026, and involves 16,499 electrodes, with 8,327 distributed in the U.S. and 8,172 outside the U.S. The product is a pre-gelled, self-adhesive therapy electrode that reduces energy delivered to the patient by a factor of 4:1.
The electrodes were distributed nationwide in the U.S., including states such as Alaska, Alabama, Arizona, and others, and internationally to Australia, Canada, Hong Kong, Japan, Mexico, Malaysia, Netherlands, New Zealand, and Taiwan. The delamination may affect defibrillation.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the lot code and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Catalog Numbers: 11101-000016
- UDI-DI
- 00721902629013
- Lot code
- 315303
- 315639
- 315858
- 316007
- 320529
- 318931
Catalog Number: 11101-000017
- UDI-DI
- 00721902682483
- Lot code
- 315303
- 315639
- 315858
- 316007
- 320529
- 318931
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution including in the states of Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, and West Virginia. The countries of Australia, Canada, Hong Kong, Japan, Mexico, Malaysia, Netherlands, New Zealand, and Taiwan.
- Company
- Physio-Control, Inc.Redmond, Washington
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98257
- Recall number
- Z-1544-2026
- Quantity recalled
- 16,499 electrodes (US/OUS: 8327/8172)
All recalls from Physio-Control, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
