Ethicon Recalls VICRYL Sutures Due to Labeling Mismatch
Ethicon, Inc. is recalling VICRYL, VICRYL Plus, and PDS sutures because the product may not match the sales unit carton and foil label.
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, and the hazard is a labeling mismatch rather than a direct physical defect or contamination, fitting the criteria for moderate severity involving minor labeling errors or precautionary measures.
Plain-English summary
Ethicon, Inc. is recalling VICRYL Suture, VICRYL Plus Suture, and PDS Suture products. The recall is due to a potential discrepancy where the actual product may not match the information printed on the sales unit carton and foil label.
The affected products include various sizes and types of VICRYL sutures, such as VICRYL SUTURE 18"(45CM) and VICRYL CT VIO 8X18IN. The total quantity involved is 550,681 units. Distribution was worldwide, including the United States, Australia, Belgium, Canada, China, Israel, Japan, Puerto Rico, and Singapore.
Healthcare providers and consumers should check their inventory for the specific lot numbers listed in the official recall notice. If a product is found to be mislabeled, it should be removed from use and returned to Ethicon, Inc. according to their instructions.
The recalled product
- Product
- VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR…
- Manufacturer
- Ethicon, Inc.
- Hazard
- Affected units
- 550,681
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Ethicon, 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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