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Use caution Medical device recall · FDA · Published May 15, 2019

Ethicon ENSEAL X1 Tissue Sealer Recall: Intraoperative Bleeding Risk

Ethicon recalls ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft (NSLX145C) due to reported bleeding risks during surgery. Affected units include all lot numbers sold.

🇺🇸 FDA recall #Z-1890-2019Medical deviceEthicon ›
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Recalling firmEthicon Endo-Surgery Inc4545 Creek Rd · Blue Ash, OH 45242-2803
✎ GovInfoNow plain-language explainer

Ethicon is recalling its ENSEAL X:1 Curved Jaw Tissue Sealer 45cm Shaft (product code NSLX145C) because of reported cases of bleeding during surgery. This recall affects all units sold, and healthcare providers should stop using the product to prevent potential complications. Read more at govinfonow.com/recall/67921-ethicon-enseal-x1-tissue-sealer-recall-intraoperative-bleeding-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/67921-ethicon-enseal-x1-tissue-sealer-recall-intraoperative-bleeding-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1890-2019

Cite this page

“Ethicon ENSEAL X1 Tissue Sealer Recall: Intraoperative Bleeding Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67921-ethicon-enseal-x1-tissue-sealer-recall-intraoperative-bleeding-risk. Based on FDA recall #Z-1890-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1890-2019%22&limit=1).

Ethicon Endo-Surgery Inc recalled the Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft due to a risk of intraoperative bleeding, according to the FDA. The agency announced the Class II recall on May 15, 2019.

How to tell if you have it

  • Brand: Ethicon
  • Product: ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft
  • Product Code: NSLX145C
  • Lot numbers: All lot numbers

The hazard

The recall addresses an observed reported incidence rate for harm associated with intraoperative bleeding. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Ethicon Endo-Surgery Inc has had 12 other recalls since October 23, 2017. Recent brand recalls include the September 11, 2025 recall of ECHELON LINEAR Cutters Reload 80mm Blue for unsterilized risk and the April 22, 2025 recall of Endopath Echelon Vascular White Reload for instrument lockout risk. Other recent recalls of similar products include the March 3, 2026 Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall and the July 9, 2026 Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall.

How to tell if you have this one

Check for the product code NSLX145C on the ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft. All lot numbers are affected, so any unit with this code should be recalled.

  • Brand
    Ethicon
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM
Recall numberProduct, codes & lotsQuantity
Z-1888-2019Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C; All lot numbers228 boxes
Z-1889-2019Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C; All lot numbers1059 boxes
Z-1890-2019Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C; All lot numbers308 boxes
Based on the official FDA remedy

What to do — step by step

  1. Stop Using It Now

    Healthcare providers should stop using the ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft (product code NSLX145C) immediately to prevent bleeding risks during surgery.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

1. Firm started the recall: May 15, 201912. FDA classified it Class II: Jun 26, 201923. Published in FDA’s Enforcement Report: Jul 3, 201934. FDA terminated the recall: Jun 11, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1890-2019 (May 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1890-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA