The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0882-2022·Announced 2022-04-13

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category
Medical Device — Cardiac / Defibrillator
Hazard
Affected units
331,712

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.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Philips North America 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 →

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