Ethicon Endo-Surgery Inc
41 recalls on record · Latest: Oct 22, 2025
FDA Devices Moderate Oct 22, 2025
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
FDA Devices Critical May 28, 2025
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
FDA Devices Moderate Feb 7, 2024
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface …
FDA Devices Moderate Sep 1, 2021
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Produc…
FDA Devices Moderate Dec 18, 2019
Ligamax 5 mm Endoscopic Multiple Clip Applier
FDA Devices Critical Nov 6, 2019
ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
FDA Devices Critical Nov 6, 2019
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
FDA Devices Critical Nov 6, 2019
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
FDA Devices Moderate Jul 3, 2019
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
FDA Devices Moderate Jul 3, 2019
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
FDA Devices Moderate Jul 3, 2019
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
FDA Devices Critical May 22, 2019
Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers availab…
FDA Devices Critical May 22, 2019
Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers availab…
FDA Devices Critical May 22, 2019
Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…
FDA Devices Critical May 22, 2019
Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…
FDA Devices Critical May 22, 2019
Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers availab…
FDA Devices Critical May 22, 2019
Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available…
FDA Devices Critical May 22, 2019
Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…
FDA Devices Critical May 22, 2019
Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers availab…
FDA Devices Critical May 22, 2019
Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available…
FDA Devices Critical May 22, 2019
Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available…
FDA Devices Moderate Jan 16, 2019
PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have appl…
FDA Devices Moderate Jun 6, 2018
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The…
FDA Devices Moderate May 23, 2018
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
FDA Devices Moderate May 23, 2018
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
FDA Devices Moderate May 23, 2018
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
FDA Devices Moderate May 23, 2018
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
FDA Devices Moderate Feb 28, 2018
Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and sid…
FDA Devices Moderate Jun 7, 2017
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
FDA Devices Moderate Oct 26, 2016
Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general…
FDA Devices Moderate Nov 25, 2015
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions wh…
FDA Devices Critical Sep 2, 2015
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to pro…
FDA Devices Moderate May 27, 2015
ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimall…
FDA Devices Moderate Sep 17, 2014
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Steri…
FDA Devices Moderate Nov 13, 2013
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical…
FDA Devices Moderate Nov 13, 2013
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical…
FDA Devices Moderate Nov 13, 2013
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band …
FDA Devices Moderate Jul 31, 2013
LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a…
FDA Devices Moderate Jul 31, 2013
Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation …
FDA Devices Moderate Mar 13, 2013
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
FDA Devices Moderate Feb 6, 2013