MediPress Pneumatic Compression System Recalled for Lack of Clearance
Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.
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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a regulatory compliance issue (lack of clearance) rather than a reported physical injury, fitting the Moderate category for low-risk or precautionary issues without reported harm.
Plain-English summary
Compass Health Brands is recalling the MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S. The recall affects all serial numbers and lots of this specific model.
The recall was initiated because a product design change did not receive proper premarket clearance and lacks a 510(k). This regulatory deficiency means the device was not fully cleared by the FDA for its current configuration.
The affected devices were distributed domestically to numerous states including Alabama, Arizona, California, Florida, New York, and Texas, as well as internationally to Canada. Consumers who possess this device should contact Compass Health Brands for instructions on how to proceed.
The recalled product
- Product
- MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S
- Manufacturer
- Compass Health Brands (Corporate Office)
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 Serial Numbers/Lots
Distribution
Part of a larger recall action
This product is one of 6 recalled by Compass Health Brands (Corporate Office) 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.
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