Severity
Moderate
FDA Devices recall · Reported September 3, 2025
Regulatory documentation error and misleading color packaging claim.
Zhejiang Luyao Electronics Technology Co., Ltd. recalled Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: S… - a moderate-severity action.
Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: S… was recalled by Zhejiang Luyao Electronics Technology Co., Ltd. in September 3, 2025. Reason: Regulatory documentation error and misleading color packaging claim.. Check the official notice for the remedy. Verify recall #Z-2463-2025 with the FDA Devices before acting.
The recall
Zhejiang Luyao Electronics Technology Co., Ltd. issued this moderate-severity FDA Devices recall-Regulatory documentation error and misleading color packaging claim..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2463-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2463-2025) was formally reported on September 3, 2025, with the manufacturer initiating the action on January 17, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Zhejiang Luyao Electronics Technology Co., Ltd. is listed as the recalling firm, operating out of Wenzhou. Federal records list the affected scope as 3705 US.
The documented reason for this recall is: Regulatory documentation error and misleading color packaging claim. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the country of Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
3705 US
Related Recalls
6
3 from same agency
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 for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.
Regulatory documentation error and misleading color packaging claim.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2463-2025 |
| Date reported | September 3, 2025 |
| Date initiated | January 17, 2025 |
| Recalling firm | Zhejiang Luyao Electronics Technology Co., Ltd. |
| Firm location | Wenzhou |
| Affected scope | 3705 US |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 3, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.