PDS II Polydioxanone Sutures Recalled Due to Compromised Sterility
Ethicon is recalling 56,952 units of PDS II polydioxanone sutures distributed worldwide because a packaging defect resulted in compromised sterility, which could lead to infection. No illnesses have been reported.
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: FDA Class II recall of a surgical suture with compromised sterility from a packaging defect. No infections or injuries have been reported, but the risk of infection from compromised sterility—a critical property of surgical devices—meets the criteria for High severity.
Plain-English summary
Ethicon, Inc. is recalling PDS II (polydioxanone) sutures used in general soft tissue approximation, including pediatric cardiovascular tissue, microsurgery, and ophthalmic surgery. The sutures are absorbable with extended wound support up to six weeks.
The recall affects 56,952 units distributed worldwide, including the United States, Puerto Rico, and additional countries in North America, South America, Europe, Asia, Africa, and the Middle East.
A defect on a specific packaging machine created a hole in the primary packaging, resulting in compromised sterility. Compromised sterility could result in infection during surgical procedures. No illnesses or injuries have been reported.
The recalled product
- Product
- PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended…
- Manufacturer
- Ethicon, Inc.
- Affected units
- 56,952
Distribution
Part of a larger recall action
This product is one of 6 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.
See all 6 products in this recall →Related recalls
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