Browse Device Recalls
54 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 54 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 54 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 11, 2025 | ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection... | The devices were shipped unsterilized. | Class II | Ethicon Endo-Surgery Inc |
| 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 lockout during surgical... | Class I | Ethicon Endo-Surgery Inc |
| 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 sequence, without m... | Class II | Ethicon Endo-Surgery Inc |
| 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 button potentially resul... | Class II | Ethicon Endo-Surgery Inc |
| 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 button potentially resul... | Class II | Ethicon Endo-Surgery Inc |
| 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 | Ethicon Endo-Surgery Inc |
| Nov 7, 2019 | Ligamax 5 mm Endoscopic Multiple Clip Applier | A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in... | Class II | Ethicon Endo-Surgery Inc |
| 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 jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| 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 jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| 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 jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| 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 jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Ethicon Endo-Surgery Inc |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Ethicon Endo-Surgery Inc |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Ethicon Endo-Surgery Inc |
| 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 completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| 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 completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| 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 completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| 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 completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| 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 completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| 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 completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| 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 completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| 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 completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| 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 completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| 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 completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| 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 completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| 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 completely form staples. | Class I | Ethicon Endo-Surgery Inc |
| Dec 7, 2018 | PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: ... | Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially caus... | Class II | Ethicon Endo-Surgery Inc |
| Dec 7, 2018 | PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: Th... | Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially caus... | Class II | Ethicon Endo-Surgery Inc |
| 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 continuous or inadv... | Class II | Ethicon Endo-Surgery Inc |
| 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 continuous or inadv... | Class II | Ethicon Endo-Surgery Inc |
| 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 trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| 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 trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| 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 trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| 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 trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| 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 trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| 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 formed staple height spec... | Class II | Ethicon Endo-Surgery Inc |
| 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 use cases. | Class II | Ethicon Endo-Surgery Inc |
| 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 device could fail under... | Class II | Ethicon Endo-Surgery Inc |
| 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 device could fail under... | Class II | Ethicon Endo-Surgery Inc |
| 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 provided by the packaging. | Class II | Ethicon Endo-Surgery Inc |
| May 13, 2015 | SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An inte... | Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have ... | Class I | Ethicon Endo-Surgery Inc |
| Feb 26, 2015 | ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Produ... | During an internal inspection of the production process the firm discovered an issue which may ca... | Class II | Ethicon Endo-Surgery Inc |
| 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 fire an unformed staple. | Class II | Ethicon Endo-Surgery Inc |
| 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 to pass the test req... | Class II | Ethicon Endo-Surgery Inc |
| 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 to pass the test req... | Class II | Ethicon Endo-Surgery Inc |
| 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 to pass the test req... | Class II | Ethicon Endo-Surgery Inc |
| 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 60mm Black Reload (EC... | Class II | Ethicon Endo-Surgery Inc |
| 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 Endoscopic Rotating ... | Class II | Ethicon Endo-Surgery Inc |
| 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 Endoscopic Rotating ... | Class II | Ethicon Endo-Surgery Inc |
| 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 Endoscopic Rotating ... | Class II | Ethicon Endo-Surgery Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.