Heel Snuggler devices recalled for labeling changes without FDA approval
Philips North America recalled approximately 2.5 million Heel Snuggler units because labeling was modified after FDA clearance without obtaining updated regulatory approval.
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: This FDA Class II recall addresses a regulatory compliance issue regarding labeling changes that exceed the scope of existing FDA clearance. No illnesses, injuries, or specific health hazards have been reported.
Plain-English summary
Philips North America is recalling Heel Snuggler devices (Reference # 989805603411 99047) distributed nationwide in the US and Canada. After receiving FDA clearance, Philips modified the product labeling. These changes do not fall within the scope of the existing FDA clearance, and the devices cannot be legally distributed or sold without new 510(k) clearance from the FDA.
Approximately 2,515,200 units are affected. All units are impacted by this recall.
Consumers and healthcare facilities in possession of these devices should contact Philips North America for information regarding the recall and available options.
The recalled product
- Product
- Heel Snuggler, Reference # 989805603411 99047
- Manufacturer
- Philips North America Llc
- Category
- Medical Device
- Hazard
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 units are impacted
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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.
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