Class 2 Device Recall PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes

• Date Initiated by Firm: January 21, 2026
• Date Posted: March 10, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1544-2026
• Recall Event ID: 98257
• PMA Number: P160012
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• 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).
• Code Information: Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Lot Numbers: 315303, 315639, 315858, 316007, 320529, 318931
• FEI Number: 3015876
• Recalling Firm/ Manufacturer: Physio-Control, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: Joyce Staggs; 425-867-4597
• Manufacturer Reason for Recall: Due to pediatric defibrillator electrode delamination
• FDA Determined 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 RSRecall@Stryker.com 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 medtechsup@stryker.com.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MKJ