PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 007219026

FDA device recall Z-1544-2026 · posted 2026-03-10 · Open, Classified

Recall details

Recalling firm

Physio-Control, Inc.

Reason for recall

Due to pediatric defibrillator electrode delamination

Action taken

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.

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

MKJ

Quantity affected

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,

Date initiated

2026-01-21

Date posted

2026-03-10

Location

Redmond, WA