EXP Recalls PhysioMesh Surgical Mesh Due to Regulatory Non-Compliance
EXP Pharmaceutical Services Corp is recalling two units of PhysioMesh surgical mesh because the company failed to register as a medical device establishment or maintain its own quality system.
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. The source text identifies a regulatory and quality system compliance failure rather than a specific product defect or reported injury, aligning with the 'Moderate' severity criteria for minor or procedural issues.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling two units of PhysioMesh Flexible Composite Mesh (10cm x 15cm). The product is a sterile, single-use surgical mesh with OEM Catalog number PHY1015V, originally manufactured by Ethicon and repackaged by EXP.
The recall was initiated because EXP did not register as a medical device establishment, did not list the devices being recalled, and did not establish its own quality system. Instead, the company relied on the fact that its vendors were registered and had their own quality systems.
The affected units were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare providers should stop using the product and contact EXP Pharmaceutical Services Corp for further instructions.
The recalled product
- Product
- Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1015V; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric
- Manufacturer
- EXP Pharmaceutical Services Corp
- Category
- Medical Device — Surgical Mesh
- Affected units
- 2
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)
- OEM Catalog number PHY1015V.
Distribution
Part of a larger recall action
This product is one of 42 recalled by EXP Pharmaceutical Services Corp 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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