Atrium Medical Recalls C-QUR Edge Mesh Due to Packaging Adhesion
Atrium Medical is recalling C-QUR Edge Mesh products because the coated mesh can adhere to the inner packaging liner when exposed to high humidity.
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 describes a packaging integrity issue (adhesion due to humidity) without reporting any injuries, illnesses, or structural defects in the device itself, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Atrium Medical Corporation is recalling C-QUR Edge Mesh products in all sizes and shapes. These medical devices are intended for use in soft tissue deficiencies. The recall involves 1,501 units with lot numbers 10405513 and higher.
The recall was initiated because the coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions. This issue may affect the usability or integrity of the device packaging.
The affected products were distributed nationwide in the United States, including Puerto Rico, as well as in numerous international locations including Australia, Austria, Bahrain, Brazil, Canada, Chile, Colombia, the Dominican Republic, Ecuador, El Salvador, France, Germany, Great Britain, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Nicaragua, Norway, Panama, Peru, Portugal, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, and Venezuela. Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using the recalled products.
The recalled product
- Product
- C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
- Manufacturer
- Atrium Medical Corporation
- Affected units
- 1,501
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)
- Product lines with lot number 10405513 and higher
Distribution
Part of a larger recall action
This product is one of 4 recalled by Atrium Medical Corporation 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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