Ethicon Recalls Polyester Sutures Due to Potential High Endotoxin Levels
Ethicon, Inc. is recalling specific lots of ETHIBOND EXCEL polyester sutures because raw materials 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device with a potential for significant health impact (high endotoxin levels), meeting the criteria for a Severe rating.
Plain-English summary
Ethicon, Inc. is recalling 1,296 units of ETHIBOND EXCEL polyester sutures (Product Code: X425H, Lot Code: PBQ426). The recall is 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 the ETHIBOND Green 75cm USP1 Single Armed CT-1 suture, intended for general soft tissue approximation and ligation in cardiovascular, ophthalmic, and neurological procedures. The recall is classified as Class II by the FDA.
The product was distributed nationwide in the United States (specifically in IA, NJ, RI, TX, and WV) and in Canada. Healthcare providers and facilities should check their inventory for this specific lot code and discontinue use if found.
The recalled product
- Product
- ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H 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
- 1,296
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: PBQ426
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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