Philips Infant/Child Defibrillator Pads Recalled for Incorrect Age Labeling
Philips is recalling infant/child defibrillator pads due to incorrect age range labeling on the foil packaging.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding age range. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are classified as Moderate.
Plain-English summary
Philips North America LLC is recalling 181,894 units of the Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A. The recall is initiated because the foil packaging displays an incorrect age range of "8+ yrs." The affected lots are identified by numbers Y070115-04 through Y011118-07.
The infant/child pad cartridge is designed for use with the defibrillator. The source text notes that these pads should not be used on adults because they deliver lower energy (50 J) compared to adult pads (150 J), which may render them ineffective for adult patients. The products were distributed across all 50 U.S. states, Puerto Rico, and numerous international locations including Canada, the United Kingdom, and Australia.
Consumers should check the model number and lot numbers on their cartridges to determine if they are affected. If the product matches the recalled description, users should follow instructions from Philips or the FDA regarding return or replacement.
The recalled product
- Product
- Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
- Manufacturer
- Philips North America LLC
- Hazard
- Affected units
- 181,894
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 (2)
- Model# M5072A
- Lots #s Y070115-04 - Y011118-07
Distribution
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