Recall Z-1544-2026 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
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 o
| Date | Mar 10, 2026 (initiated Jan 21, 2026) |
| Status | Open, Classified |
| Reason | Due to pediatric defibrillator electrode delamination |
| 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.