Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk
Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.
What this means for you
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 involves a medical device with a risk of harm (intraoperative bleeding) where injury has been reported, but the source does not specify FDA Class I or report fatalities, fitting the High severity criteria.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 308 boxes of ENSEAL X1 Curved Jaw Tissue Sealers with a 45cm shaft (Product Code: NSLX145C). The recall covers all lot numbers of this specific device.
The recall was initiated because of a reported incidence rate of harm associated with intraoperative bleeding. The devices were distributed nationwide in the United States as well as in Canada, Australia, and Belgium.
Healthcare providers and facilities should stop using the affected devices and contact Ethicon Endo-Surgery Inc for instructions on return or replacement.
The recalled product
- Product
- Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
- Manufacturer
- Ethicon Endo-Surgery Inc
- Hazard
- Affected units
- 308
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)
- All lot numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Ethicon Endo-Surgery 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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