Z-1544-2026Class II

PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI...

Name: Z-1544-2026 PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI...
Creator: Physio-Control, Inc.
Published: 2026-01-21
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2026-01-21 / Open, Classified

FDA source

Physio-Control, Inc. began a recall of PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017... on 2026-01-21. FDA classified it as Class II and gives the reason as "Due to pediatric defibrillator electrode delamination". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1544-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-21
Posted: 2026-03-10
Recalling firm: Physio Control, Inc.
Product: 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).
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Due to pediatric defibrillator electrode delamination
FDA root cause: Unknown/Undetermined by firm
Action: 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].
Quantity in commerce: 16,499 electrodes (US/OUS: 8327/8172)
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 codes and lots: Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Lot Numbers: 315303, 315639, 315858, 316007, 320529, 318931

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1544-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1544-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-10

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)