Medi-Trace Pediatric Defibrillation Electrodes Recalled for Arcing Risk
FDA is recalling Medi-Trace Cadence Pediatric Defibrillation Electrodes because arcing or sparking may damage the leadwire, preventing the device from delivering appropriate energy to patients.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (thermal damage to leadwire) that could prevent the delivery of life-saving energy, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling the Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode (Product ID: 22550P). The recall involves 7,485 sets of 2 units. The product is intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
The recall was initiated because the defibrillation electrodes may arc or spark, which can result in thermal damage to the leadwire. This damage could render the device incapable of delivering the appropriate energy or shock to the patient. The affected lot numbers are 228651, 232146, 235646X, 301833X, and 303928X.
The product was distributed worldwide, including nationwide in the United States and in Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa. The FDA has classified this as a Class II recall. Users should stop using the affected devices and contact the manufacturer, Covidien LLC, for further instructions.
The recalled product
- Product
- Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
- Manufacturer
- Covidien LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Numbers: 228651
- 232146
- 235646X
- 301833X
- 303928X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Covidien LLC
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Same hazard · arcing
See all →- HighCascade IOMAX Cortical Module recalled for potential electrical shock hazard
FDA (Devices) · 2024-05-29
- SevereResearch Products Steam Humidifiers Recalled for Fire Hazard
CPSC · 2023-06-22
- HighIsopure ACDS Hemodialysis Equipment Recalled for Electrical Shock Risk
FDA (Devices) · 2022-09-21
- SevereTesla Recalls Universal Mobile Connector Adapters Due to Fire Risk
NHTSA · 2016-12-06
- SevereWhirlpool Recalls Microwave Hood Combinations Due to Fire Hazard
CPSC · 2016-08-25