Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
Reported: July 3, 2019 Initiated: May 15, 2019 #Z-1890-2019
Product Description
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
Reason for Recall
Observed reported incidence rate for harm associated with intraoperative bleeding
Details
- Recalling Firm
- Ethicon Endo-Surgery Inc
- Units Affected
- 308 boxes
- Distribution
- Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM
- Location
- Blue Ash, OH
Frequently Asked Questions
What product was recalled? ▼
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C. Recalled by Ethicon Endo-Surgery Inc. Units affected: 308 boxes.
Why was this product recalled? ▼
Observed reported incidence rate for harm associated with intraoperative bleeding
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 3, 2019. Severity: Moderate. Recall number: Z-1890-2019.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11