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, which typically indicates a temporary or medically reversible adverse health consequence. The source text does not report any injuries, illnesses, or fatalities, and the hazard is regulatory (lack of clearance) rather than a direct physical defect causing harm.
Plain-English summary
Compass Health Brands is recalling the MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S. The recall was initiated because a product design change did not receive proper premarket clearance and lacks a 510(k) submission.
The affected devices were distributed domestically to numerous states including Alabama, Arizona, California, Florida, New York, and Texas, as well as internationally to Canada. The recall applies to all serial numbers and lots of the specified model.
Consumers and healthcare providers should stop using the affected devices and contact Compass Health Brands for further instructions regarding the recall.
The recalled product
- Product
- MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-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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