MediPress Pneumatic Compression System Recalled for Missing Premarket Clearance
Compass Health Brands is recalling the MediPress pneumatic compression system because a design change lacked proper FDA premarket clearance.
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 2/5 (Moderate).
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 cites a regulatory documentation issue (missing 510(k)) rather than a specific physical hazard or reported injury, aligning with the Moderate severity criteria for minor labeling or documentation issues.
Plain-English summary
Compass Health Brands is recalling the MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-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 on the recall.
The recalled product
- Product
- MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-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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