Ethicon Endo-Surgery Inc
Complete recall history across all FDA and CPSC categories — 54 total recalls
Ethicon Endo-Surgery Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (54)
FDA medical device enforcement actions by Ethicon Endo-Surgery Inc. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 11, 2025 | ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection... | The devices were shipped unsterilized. | Class II |
| Apr 22, 2025 | Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 ro... | Firm has received an increase in reports regarding inadvertent instrument loc... | Class I |
| Dec 11, 2023 | ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON... | There is the potential for incomplete staple line formation during the firing... | Class II |
| Jul 20, 2021 | HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisi... | An internal component may be cracked and become lodged behind the energy butt... | Class II |
| Jul 20, 2021 | HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisio... | An internal component may be cracked and become lodged behind the energy butt... | Class II |
| Jun 3, 2021 | ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or... | Mislabeled: Labeled on the package as 60mm contains 45mm devices | Class II |
| Nov 7, 2019 | Ligamax 5 mm Endoscopic Multiple Clip Applier | A potential exists that certain LIGAMAX devices within the impacted lots may... | Class II |
| Oct 3, 2019 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code P... | The staplers may contain an out of specification anvil component within the j... | Class I |
| Oct 3, 2019 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code P... | The staplers may contain an out of specification anvil component within the j... | Class I |
| Oct 3, 2019 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code P... | The staplers may contain an out of specification anvil component within the j... | Class I |
| Oct 3, 2019 | ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A | The staplers may contain an out of specification anvil component within the j... | Class I |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C | Observed reported incidence rate for harm associated with intraoperative blee... | Class II |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C | Observed reported incidence rate for harm associated with intraoperative ble... | Class II |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C | Observed reported incidence rate for harm associated with intraoperative ble... | Class II |
| Apr 11, 2019 | Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and c... | Class I |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The E... | The staplers may have an insufficient firing stroke to break the washer and c... | Class I |
| Apr 11, 2019 | Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and c... | Class I |
| Apr 11, 2019 | Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and c... | Class I |
| Apr 11, 2019 | Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and c... | Class I |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The E... | The staplers may have an insufficient firing stroke to break the washer and c... | Class I |
| Apr 11, 2019 | Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon End... | The staplers may have an insufficient firing stroke to break the washer and c... | Class I |
| Apr 11, 2019 | Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and c... | Class I |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The E... | The staplers may have an insufficient firing stroke to break the washer and c... | Class I |
| Apr 11, 2019 | Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The E... | The staplers may have an insufficient firing stroke to break the washer and c... | Class I |
| Apr 11, 2019 | Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and c... | Class I |
| Apr 11, 2019 | Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon E... | The staplers may have an insufficient firing stroke to break the washer and c... | Class I |
| Dec 7, 2018 | PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: ... | Hemorrhoidal Circular Stapler may have been assembled without a washer, this ... | Class II |
| Dec 7, 2018 | PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: Th... | Hemorrhoidal Circular Stapler may have been assembled without a washer, this ... | Class II |
| May 3, 2018 | HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length ... | The devices may have been assembled with an internal component that may cause... | Class II |
| May 3, 2018 | HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length ... | The devices may have been assembled with an internal component that may cause... | Class II |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to t... | Class II |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to t... | Class II |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to t... | Class II |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to t... | Class II |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to t... | Class II |
| Oct 23, 2017 | Disposable Curved Circular Staplers Product Usage: Staplers have applicat... | There is a potential for the devices to create staples that do not meet forme... | Class II |
| Mar 31, 2017 | Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM | There is a risk that the pinion gear in the device could fail under extreme u... | Class II |
| Jul 15, 2016 | Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOP... | Quality control identified a component issue where the pinion gear in the dev... | Class II |
| Jul 15, 2016 | Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH E... | Quality control identified a component issue where the pinion gear in the dev... | Class II |
| Sep 23, 2015 | HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45c... | Complaints of holes in Tyvek which can compromise the sterile barrier provide... | Class II |
| May 13, 2015 | SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An inte... | Ethicon has found that disinfecting methods not specified in the Instructions... | Class I |
| Feb 26, 2015 | ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Produ... | During an internal inspection of the production process the firm discovered a... | Class II |
| Aug 12, 2014 | PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR3... | The device may have a non-conforming component that may cause the device to f... | Class II |
| Sep 30, 2013 | Adjustable Gastric Band, packaged alone in transparent PETG inner and outer b... | During aging studies, the firm determined that the gastric belts were unable ... | Class II |
| Sep 30, 2013 | Adjustable Gastric Band, packaged alone in transparent PETG inner and outer b... | During aging studies, the firm determined that the gastric belts were unable ... | Class II |
| Sep 30, 2013 | Adjustable Gastric Band, packaged alone in transparent PETG inner and outer b... | During aging studies, the firm determined that the gastric belts were unable ... | Class II |
| May 13, 2013 | ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack ... | Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 6... | Class II |
| Apr 12, 2013 | LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk n... | Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L ... | Class II |
| Apr 12, 2013 | LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Tra... | Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L ... | Class II |
| Apr 12, 2013 | LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Pro... | Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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