Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Philips Recalled by Philips North America LLC Due to Infant/Child defibrillator pads contain incorrect labeling. This could...

Date: July 16, 2021
Company: Philips North America LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips North America LLC directly.

Affected Products

Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator

Quantity: 19,840 units

Why Was This Recalled?

Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips North America LLC

Philips North America LLC has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report