Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk
Ethicon is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to a reported incidence of intraoperative bleeding.
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 reported incidence of harm associated with intraoperative bleeding, which aligns with the rubric criteria for Severe severity involving significant injury reports.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 1,059 boxes of ENSEAL X1 Curved Jaw Tissue Sealers with a 37cm shaft (Product Code: NSLX137C). The recall covers all lot numbers of this specific device configuration.
The recall was initiated because of a reported incidence of harm associated with intraoperative bleeding. The agency has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected devices were distributed nationwide and in Canada, Australia, and Belgium. Healthcare providers and facilities should stop using the recalled devices and contact Ethicon Endo-Surgery Inc for instructions on return or replacement.
The recalled product
- Product
- Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
- Manufacturer
- Ethicon Endo-Surgery Inc
- Hazard
- Affected units
- 1,059
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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