Ethicon Proceed Surgical Mesh Recalled for Potential Sterility Compromise
Ethicon is recalling 223 units of Proceed Surgical Mesh due to a possible incomplete packaging seal that may have compromised sterility and caused delamination.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a sterility compromise poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ethicon, Inc. is recalling 223 units of Proceed Surgical Mesh, product codes PCDB1, PCDT1, and PCDJ1. The device is used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
The recall was initiated because an incomplete seal on the packaging may have compromised the sterility of the device. This defect also introduced the potential for delamination of the mesh material.
The affected units were distributed in the United States, including the states of Florida, New Jersey, Missouri, Illinois, Pennsylvania, North Carolina, Texas, Tennessee, Washington, Idaho, Utah, West Virginia, Mississippi, California, Alabama, Massachusetts, Georgia, Louisiana, and Oklahoma. Specific lot numbers include GGG157 for PCDB1, GGG158 for PCDT1, and GGG159 for PCDJ1. Healthcare providers and patients should contact Ethicon, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Surgical Mesh
- Affected units
- 223
Distribution
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