Philips infant/child defibrillator pads recalled for gel separation defect
Philips is recalling 331,712 infant and child defibrillator pads worldwide due to potential gel separation from the pad backing. The gel may fold onto itself or separate nearly completely, leaving reduced surface coverage on the pad.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. The hazard—potential inadequate gel coverage affecting pad contact—represents a risk-of-harm scenario in a critical life-saving device, but no actual incidents have been reported.
Plain-English summary
Philips is recalling model M5072A infant and child Smart Pads Cartridges, used with Philips HeartStart defibrillators. The recall affects approximately 331,712 units distributed worldwide, including throughout the United States, Puerto Rico, Guam, and numerous other countries.
During manufacturing or use, the gel may separate from the foam or tin backing when the pads are peeled from the plastic liner. This can cause the gel to fold onto itself, reducing the effective surface area, or to separate almost completely, leaving only a minimal amount of gel on the pad.
These pads are designed for use in infants and children up to 8 years old (weighing less than 55 lbs or 25 kg) with Philips HeartStart defibrillators. All lots of this product are affected by the recall.
The recalled product
- Product
- Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS
- Manufacturer
- Philips North America LLC
- Hazard
- gel-separation
- inadequate-contact
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 (1)
- ALL LOTS
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03