Leg massagers recalled over documentation error and misleading color packaging claim
HoMedics Air Compression Leg Massagers, model SR-160HJ, are recalled for a regulatory documentation error and a misleading color packaging claim. The record states the affected lots do not present a risk of harm.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Rubric level 1 covers documentation issues and packaging-only problems; the record describes a documentation error and a packaging claim and states the lots present no risk of harm.
Plain-English summary
The HoMedics Air Compression Leg Massager, model and catalog number SR-160HJ, UDI 00031262108746, is being recalled. It is a powered inflatable tube massager used on the leg and indicated for the temporary relief of minor discomfort. All lots are affected. The recall covers 3,705 units in the United States, with distribution also in Canada.
The recall was issued for a regulatory documentation error and a misleading colour claim on the packaging. The FDA classified the action as Class II. The recall record states that although all lots are affected, they do not present a risk of harm.
Owners should follow the manufacturer's instructions if they wish to return the product.
The recalled product
- Product
- Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massager used on the leg. The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and…
- Manufacturer
- Zhejiang Luyao Electronics Technology Co., Ltd.
- Affected units
- 3,705
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)
- UDI: 00031262108746 Product Code: IRP Lot # : All lots affected
- however they do not present risk of harm. Expiration Date: 2 YEARS
Distribution
Distributed nationwide across the United States.
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