The Recall Desk
ModerateFDA (Devices)·Z-0507-2022·Announced 2022-01-26

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.

What this means for you

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
  • labeling-non-compliance

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.

Related recalls

Same category