Blue Ash, OH, United States
Ethicon Endo-Surgery Inc recalls
13 recalls recorded since 2018, most recently on 11 September 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls13
Ongoing (FDA)4
Terminated or completed9
Class I (FDA)3
Ongoing Class II Medical devices
- Recall started
- 11 September 2025
- Reason
- The devices were shipped unsterilized.
- Distribution
- International distribution to the countries of United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0147-2026
- ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Ongoing Class I Medical devices
- Recall started
- 22 April 2025
- Reason
- 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.
- Distribution
- US distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1746-2025
- Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Ongoing Class II Medical devices
- Recall started
- 11 December 2023
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0834-2024
- ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
Ongoing Class II Medical devices
- Recall started
- 20 July 2021
- Reason
- 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
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Austria, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Latvia, Leban
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2356-2021, Z-2355-2021
- HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
- HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
Terminated Class II Medical devices
- Recall started
- 3 June 2021
- Terminated
- 14 September 2022
- Reason
- Mislabeled: Labeled on the package as 60mm contains 45mm devices
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2326-2021
- ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and
Terminated Class II Medical devices
- Recall started
- 7 November 2019
- Terminated
- 23 April 2021
- Reason
- 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.
- Distribution
- US: Nationwide International: ARGENTINA ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHINA COLOMBIA DENMARK ESTONIA FINLAND FRANCE GERMANY INDIA INDONESIA IRELAND JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS NEW CALEDONIA NEW ZEALAND PANAMA PHILIPPINES PUERTO RICO QATAR SAUDI ARABIA SINGAPORE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0656-2020
- Ligamax 5 mm Endoscopic Multiple Clip Applier
Terminated Class I Medical devices
- Recall started
- 3 October 2019
- Terminated
- 3 June 2021
- Reason
- 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.
- Distribution
- Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0200-2020, Z-0201-2020, Z-0203-2020, Z-0202-2020
- ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
- ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
- ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
- ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
Terminated Class II Medical devices
- Recall started
- 15 May 2019
- Terminated
- 11 June 2020
- Reason
- Observed reported incidence rate for harm associated with intraoperative bleeding
- Distribution
- Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1890-2019, Z-1889-2019, Z-1888-2019
- Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
- Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
- Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
Completed Class I Medical devices
- Recall started
- 11 April 2019
- Reason
- The staplers may have an insufficient firing stroke to break the washer and completely form staples.
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Argentina, Aruba, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Honduras, India, Indonesia, Israel, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Malaysia,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1276-2019, Z-1278-2019, Z-1271-2019, Z-1274-2019, Z-1277-2019, Z-1267-2019, Z-1272-2019, Z-1275-2019, Z-1269-2019, Z-1268-2019, Z-1273-2019, Z-1270-2019
- Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of
- Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of
- Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to dia
- Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to dia
- Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of
- Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of t
- Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to dia
- Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of
- and 4 more product lines
Terminated Class II Medical devices
- Recall started
- 7 December 2018
- Terminated
- 29 April 2020
- Reason
- Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired
- Distribution
- Worldwide Distribution: US (Nationwide) and to countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, ECUADOR, EGYPT, INDIA, INDONESIA, JAPAN, KOREA, KUWAIT, LEBANON MEXICO, NICARAGUA, PAKISTAN, SAUDI ARABIA, SINGAPORE, TAIWAN URUGUAY and VIETNAM.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0696-2019, Z-0695-2019
- PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemo
- PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by m
Terminated Class II Medical devices
- Recall started
- 3 May 2018
- Terminated
- 25 November 2019
- Reason
- The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
- Distribution
- Worldwide distribution - US Nationwide. The devices were distributed to the following foreign countries: Algeria, Angola, Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egyp
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2049-2018, Z-2048-2018
- HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for so
- HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for so
Terminated Class II Medical devices
- Recall started
- 26 March 2018
- Terminated
- 8 April 2020
- Reason
- Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
- Distribution
- Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1889-2018, Z-1886-2018, Z-1887-2018, Z-1888-2018, Z-1885-2018
- 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
- 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
- 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
- 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
- 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
Terminated Class II Medical devices
- Recall started
- 23 October 2017
- Terminated
- 18 July 2019
- Reason
- There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.
- Distribution
- China
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0672-2018
- Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.