Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Defects
Davol, Inc. is recalling Composix LP with Echo PS hernia mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.
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 hazard is a packaging defect (open or weak seal) that poses a theoretical risk to sterility, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling the Composix LP with Echo PS 6x10 hernia mesh (Reorder Number: 0144610, Lot Number: HUXK1536). The recall is due to a defect where the pouch holding the sterile inflation assembly and inflation adapter may be open or have a weak seal. This issue could potentially compromise the sterile integrity of the device components.
The affected products were distributed worldwide, including nationwide in the United States and internationally to Austria, Belgium, Canada, Cyprus, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, and the United Kingdom. The device is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Healthcare providers and consumers should stop using the affected lot of the product and contact the manufacturer for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
- Manufacturer
- Davol, Inc., Subs. C. R. Bard, Inc.
- Category
- Medical Device — Hernia Mesh
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)
- Lot Number: HUXK1536
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Davol, Inc., Subs. C. R. Bard, Inc. 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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