Surgical Suture Needles Recalled Due to Manufacturing Defect
Ethicon Endo Surgery recalls PDS PLUS VIO surgical sutures with needles due to silicone curing defects during manufacturing. 792 units were distributed worldwide.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing defect in silicone curing that has not resulted in reported clinical harm, making this a precautionary recall.
Plain-English summary
Ethicon Endo Surgery, LLC is recalling PDS PLUS VIO 30IN (75CM) USP6-0 surgical sutures with needles due to silicone curing defects discovered during the manufacturing process.
The defect affects lot number 104M7E and involves improper curing of the silicone during needle manufacturing. A total of 792 units were distributed.
The recalled sutures were distributed worldwide, including to the United States and 22 other countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, and Uruguay.
Customers who received these products should discontinue use and contact Ethicon Endo Surgery for further guidance or replacement products.
The recalled product
- Product
- PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
- Manufacturer
- Ethicon Endo Surgery, LLC
- Hazard
- Affected units
- 792
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 (4)
- Product Code: PDP127H-14
- GMDN: 47362
- UDI-DI: 10705031047907
- Lot number: 104M7E
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Ethicon Endo Surgery, LLC 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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