Ethicon Recalls Ethibond Excel Polyester Sutures Due to Endotoxin Risk
Ethicon, Inc. is recalling specific lots of Ethibond Excel polyester sutures because raw materials used in manufacturing may contain high endotoxin levels.
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 is classified as FDA Class II, and the hazard involves high endotoxin levels in a medical device used in surgical procedures, representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
Ethicon, Inc. is recalling 36 units of Ethibond Excel Polyester Suture-Green 75cm USP1 Single Armed CTX (Product Code: X865W, Lot Code: PBQ797). The recall was initiated due to the possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this specific lot.
The affected product is intended for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. The recall covers distribution in the United States (specifically IA, NJ, RI, TX, WV) and Canada.
Healthcare providers and facilities should check their inventory for this specific lot code and discontinue use of the affected sutures. Consumers are not expected to have this product in their homes, as it is a medical device used in clinical settings.
The recalled product
- Product
- ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological…
- Manufacturer
- Ethicon, Inc.
- Hazard
- Affected units
- 36
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 (1)
- Lot Code:PBQ797
Distribution
Part of a larger recall action
This product is one of 2 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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