Reported Jan 26, 2022 · Ongoing
Heel Snuggler, Reference # 989805603411 99047
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Heel Snuggler, Reference # 989805603411 99047
- Lot codes and dates
- All units are impacted
- Amount recalled
- 2,509,100 units (Updated to 2,515,200 as of 2/15/22)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
This product could cause temporary or reversible health problems — stop using it.
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