Recall Z-1888-2019— Ethicon Endo-Surgery Inc

Name: FDA recall Z-1888-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-15

Class II · Terminated

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2019-05-15, terminated 2020-06-11. It names one FDA 510(k) clearance: K172580. Product: Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C. Reason: Observed reported incidence rate for harm associated with intraoperative bleeding.

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Terminated
Initiated: 2019-05-15
Terminated: 2020-06-11
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K172580 — ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft LengthEthicon Endo-Surgery, LLC·cleared 2017-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Observed reported incidence rate for harm associated with intraoperative bleeding

Data sourced from openFDA. This site is unofficial and independent of the FDA.