Philips HEARTSTART Infant/Child Defibrillator Pads Recalled for Incorrect Labeling
Philips infant/child defibrillator pads are recalled due to incorrect labeling that could delay therapy or result in lower energy delivery than indicated.
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: This is a labeling error on a critical medical device (defibrillator pads for infants/children). While no illnesses or injuries have been reported, the potential harm is significant—incorrect labeling could result in therapy delays or inadequate energy delivery. This meets the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips is recalling HEARTSTART Infant/Child Smart Pads Cartridges (model M5072A, lot Y111220-01) due to incorrect product labeling.
The labeling error could result in delayed therapy or delivery of lower energy than indicated, affecting the appropriate treatment of infant and child patients.
The recall affects approximately 19,840 units distributed worldwide, including throughout the United States and international markets.
Affected healthcare facilities and providers should verify whether they possess units from the affected lot and contact Philips North America LLC for information regarding replacements or corrective action.
The recalled product
- Product
- 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
- Manufacturer
- Philips North America LLC
- Affected units
- 19,840
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)
- Lot Y111220-01
Distribution
Distributed nationwide across the United States.
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