Z-1889-2019Class II

Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft

Name: Z-1889-2019 Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft
Creator: Ethicon Endo-Surgery Inc
Published: 2019-05-15
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2019-05-15 / Terminated

FDA source

Ethicon Endo-Surgery Inc began a recall of Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C on 2019-05-15. FDA classified it as Class II and gives the reason as "Observed reported incidence rate for harm associated with intraoperative bleeding". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1889-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-15
Posted: 2019-06-26
Terminated: 2020-06-11
Recalling firm: Ethicon Endo-Surgery Inc
Product: Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Observed reported incidence rate for harm associated with intraoperative bleeding
FDA root cause: Under Investigation by firm
Action: Ethicon issued Urgent Medical Device recall letter dated May 15, 2019 advising of product problem, health risk, and action to take: determine if you have product subject to this recall (removal) on hand and quarantine such product(s); 2. Remove the product subject to this recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall (removal) letter when communicating. 4. Complete the Business Reply Form (BRF) 5. Keep this notice visibly posted for awareness until all product subject to this recall (removal) has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall (removal) and keep a copy for your records. 6. Customers are required to return unused impacted ENSEAL X1 Curved Jaw Tissue Sealer in their inventory immediately. Questions customer complaints contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET.
Quantity in commerce: 1059 boxes
Distribution: Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1889-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1888-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-26
Z-1889-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-26
Z-1890-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-26

Product code GEI

K172580Class IIENSEAL 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)