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Ethicon Endo-Surgery Recalls
58 recalls on record · October 24, 2012 to October 22, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 22, 2025Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product N
Hazard: The devices were shipped unsterilized.
May 28, 2025Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Hazard: Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
April 9, 2025Medical DevicesFDA
Ethicon Endo Surgery, LLC recalls ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
Hazard: Identified curing issues with the silicone during the needles manufacturing process.
April 9, 2025Medical DevicesFDA
Ethicon Endo Surgery, LLC recalls PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Hazard: Identified curing issues with the silicone during the needles manufacturing process.
April 9, 2025Medical DevicesFDA
Ethicon Endo Surgery, LLC recalls PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
Hazard: Identified curing issues with the silicone during the needles manufacturing process.
April 9, 2025Medical DevicesFDA
Ethicon Endo Surgery, LLC recalls PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Hazard: Identified curing issues with the silicone during the needles manufacturing process.
February 7, 2024Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutte
Hazard: There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
September 1, 2021Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal therma
Hazard: An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
September 1, 2021Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal therm
Hazard: An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
August 25, 2021Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments h
Hazard: Mislabeled: Labeled on the package as 60mm contains 45mm devices
December 18, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Ligamax 5 mm Endoscopic Multiple Clip Applier
Hazard: A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.
November 6, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
Hazard: The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
November 6, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
Hazard: The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
November 6, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
Hazard: The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
November 6, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
Hazard: The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
July 3, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
Hazard: Observed reported incidence rate for harm associated with intraoperative bleeding
July 3, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
Hazard: Observed reported incidence rate for harm associated with intraoperative bleeding
July 3, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
Hazard: Observed reported incidence rate for harm associated with intraoperative bleeding
May 22, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are
Hazard: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
May 22, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are
Hazard: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
May 22, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are
Hazard: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
May 22, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are
Hazard: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
May 22, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (
Hazard: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
May 22, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (
Hazard: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
May 22, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (
Hazard: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
May 22, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (
Hazard: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
May 22, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are a
Hazard: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
May 22, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are a
Hazard: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
May 22, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are a
Hazard: The staplers may have an insufficient firing stroke to break the washer and completely form staples.
May 22, 2019Medical DevicesFDA
Ethicon Endo-Surgery Inc recalls Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are a
Hazard: The staplers may have an insufficient firing stroke to break the washer and completely form staples.