FDA Recalls Unapproved Compressible Limb Therapy Systems Due to Incorrect Air Compression
Won Industry Co. is recalling three unapproved Compressible Limb Therapy Systems because they have incorrect air compression level setups. The devices were distributed in Maryland, Texas, and Mexico.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves unapproved medical devices with incorrect operational settings (air compression levels), which constitutes a risk-of-harm product where injury has not yet been reported, aligning with the 'High' severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling three units of the Compressible Limb Therapy System manufactured by Won Industry Co. The recall is due to the distribution of unapproved devices that have incorrect air compression level setups. The product is intended for limb massage utilizing air compression to improve venous and lymphatic circulation.
The affected devices include leg cuffs, arm sleeves, waist pads, and air injection hoses. The recall covers three units that were distributed worldwide, specifically in Maryland and Texas in the United States, and in Mexico. No specific lot numbers or dates are provided in the source text.
Consumers who possess these devices should stop using them immediately. The devices are unapproved and have incorrect air compression settings, which may not provide the intended therapeutic effect or could pose a risk to the user. Users should contact the recalling firm, Won Industry Co., for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure…
- Manufacturer
- Won Industry Co.
- Category
- Medical Device — Limb Therapy
- Affected units
- 3
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)
- none
Distribution
Part of a larger recall action
This product is one of 2 recalled by Won Industry Co. 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.
See all 2 products in this recall →Related recalls
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