PDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility
Ethicon recalls PDS Plus Antibacterial sutures due to packaging defects that compromised sterility. The affected units may cause infection if used in surgery.
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: This Class II recall involves sterile medical devices (surgical sutures) with compromised packaging that could result in infection. Although no illnesses or injuries have been reported, this represents a risk-of-harm product where the primary safety feature (sterility) has been breached, warranting a High severity rating per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Ethicon, Inc. is recalling PDS Plus Antibacterial (polydioxanone) surgical sutures due to a packaging defect. The sutures are absorbable and intended for use in general soft tissue approximation, including pediatric cardiovascular tissue, microsurgery, and ophthalmic surgery.
A malfunction on a specific packaging machine resulted in holes in the primary packaging of affected units. These holes compromised the sterility of the product, which could result in infection if the sutures are used in surgical procedures.
The recall affects approximately 45,828 units with worldwide distribution including the United States, Puerto Rico, and countries in the Americas, Europe, Middle East, Asia, and Africa. The affected product lots are TLMJLZ (product code PDP304H), UAMKDC (PDP316H), and UBMCZA (PDP341H).
Healthcare facilities and providers with affected sutures should stop using them immediately and contact Ethicon for recall instructions.
The recalled product
- Product
- PDS Plus Antibacterial (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…
- Manufacturer
- Ethicon, Inc.
- Affected units
- 45,828
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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