MediPress Pneumatic Compression System Recalled for Missing Premarket Clearance
Compass Health Brands is recalling MediPress pneumatic compression systems because a product 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 compliance issue (missing 510(k)) rather than a specific physical hazard or reported injury, aligning with the 'voluntary precautionary' or minor compliance criteria for a Moderate score.
Plain-English summary
Compass Health Brands is recalling the MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S. The recall is being conducted because a product design change did not receive proper premarket clearance and lacks a 510(k) submission.
The affected devices were distributed domestically to multiple states including Alabama, Arizona, California, Florida, Georgia, Illinois, New York, Texas, and Washington, as well as internationally to Canada. The recall applies to all serial numbers and lots of the specified model.
Consumers who possess this device should contact Compass Health Brands for further instructions on how to proceed with the recall.
The recalled product
- Product
- MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-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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