EXP Recalls PhysioMesh Surgical Mesh Due to Registration Violations
EXP Pharmaceutical Services Corp is recalling PhysioMesh surgical mesh because the company failed to register as a medical device establishment or maintain its own quality system.
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, but the source text identifies the cause as administrative non-compliance (failure to register and maintain quality systems) rather than a specific product defect or reported injury, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling PhysioMesh Flexible Composite Mesh 15 x 15cm, a sterile, single-use surgical mesh. The product is identified by OEM Catalog number PHY1515Q and was repackaged by EXP with Ethicon as the original equipment manufacturer.
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 its vendors being registered and having 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 the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1515Q; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric
- Manufacturer
- EXP Pharmaceutical Services Corp
- Category
- Medical Device — Surgical Mesh
- Affected units
- 1
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 numberPHY1515Q.
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.
See all 42 products in this recall →Related recalls
Same manufacturer · EXP Pharmaceutical Services Corp
See all →- ModerateEXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Tracheal Stent Sizing Devices
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Unregistered Airway Stent Systems
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Versaport Bladeless Trocar Devices
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Specimen Retriever Bags Due to Registration Issues
FDA (Devices) · 2015-08-05
Same hazard · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01