Ethicon Recalls Nylon Sutures With Distorted Needles
Ethicon, LLC is recalling 4,003 units of ETHILON Nylon Suture, Product Code 697G, because needles may have distorted curvature and break during use.
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 the source describes a hazard where needles may break and cause soft tissue or vessel injury, including tearing or bleeding, but does not report any illnesses, injuries, or deaths.
Plain-English summary
Ethicon, LLC is recalling 4,003 units of ETHILON Nylon Suture, Product Code 697G. The recall involves a specific lot identified as 10B3QS with GTIN Box/Unit codes 30705031008568/10705031008564. The product was distributed internationally to Japan, Canada, and Australia.
The recall was initiated because the nylon sutures, which are indicated for general soft tissue approximation and ligation, may have needles with distorted curvature. These needles may break during use or cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Healthcare providers and consumers should check their inventory for the specific lot number and stop using the affected sutures.
The recalled product
- Product
- ETHILON Nylon Suture, Product Code 697G
- Manufacturer
- Ethicon, LLC
- Affected units
- 4,003
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)
- GTIN Box/Unit: 30705031008568/10705031008564. Lot: 10B3QS
Distribution
Distribution scope not specified by the agency.
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