Medical device recalls Moderate risk

Ethicon Endo-Surgery Inc recalls Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C

Recall date
May 15, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1888-2019
FDA classification
Class II
Brand / firm
Ethicon Endo-Surgery Inc
Sold / distributed
Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM

Why it was recalled

Observed reported incidence rate for harm associated with intraoperative bleeding

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C

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