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PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator… recallZ-1544-2026 · Physio-Control, Inc. · initiated Jan 21, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Physio-Control, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to pediatric defibrillator electrode delamination

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

On 01/21/2026, the firm sent via certified mail an "Urgent: Medical Device Recall" letter to customer informing them that Stryker was notified of complaints that the pediatric electrodes were experiencing gel delamination and could lead to a noisy or distorted ECG waveform and in addition may deliver energy to a patient without the electrode's gel barrier may result in burns. Customers are instructed to: 1. Immediately check internal inventory to locate the affected product as listed above. 2. Stop use and segregate and quarantine the affected product. 3. On the business reply form, indicate if an affected electrode is in their possession. 4. Return the business reply form by email to [email protected] to confirm receipt of this notification. 5. Upon receipt of the completed business reply form, Stryker will contact you to arrange for replacement of the electrode. 6. A return material authorization (RMA) will be provided when a replacement electrode is sent to return the affected electrodes back to Stryker. 7. Maintain awareness of this communication internally until all required actions have been completed within their facility. Ensure this letter is kept with the affected device until the correction has been completed. 8. Inform Stryker if any of the subject electrodes have been distributed to other organizations. If so, provide contact details, so Stryker can inform the recipients appropriately. For Questions - contact Customer Service +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday Friday or by email at [email protected].

Recall details

Recall number
Z-1544-2026
Status
Open, Classified
Initiated by the company
Jan 21, 2026
Posted by the FDA
Mar 10, 2026
Recalling firm
Physio-Control, Inc.
Quantity
16,499 electrodes (US/OUS: 8327/8172)
Product code
MKJ
FDA submissions
P160012
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, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Hong Kong, Japan, Mexico, Malaysia, Netherlands, New Zealand, and Taiwan.

Product description

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).

Code information (models, lots, serial numbers)

Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Lot Numbers: 315303, 315639, 315858, 316007, 320529, 318931

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

20 devices cleared under P160012 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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