ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II

26 recall(s) on record — most severe on record: Class I.

Devices registered here (2)

• Electrosurgical, Cutting & Coagulation & Accessories
  Product code GEI · Class II · General, Plastic Surgery · 21 CFR 878.4400
• Electrocautery, Gynecologic (And Accessories)
  Product code HGI · Class II · Obstetrics/Gynecology · 21 CFR 884.4120

Recalls & enforcement

• Class IIOngoing2025-09-11
  The devices were shipped unsterilized.
• Class IOngoing2025-04-22
  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 remov
• Class IIOngoing2023-12-11
  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.
• Class IIOngoing2021-07-20
  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
• Class IITerminated2021-06-03
  Mislabeled: Labeled on the package as 60mm contains 45mm devices
• Class IITerminated2019-11-07
  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.
• Class ITerminated2019-10-03
  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, postoperat
• Class IITerminated2019-05-15
  Observed reported incidence rate for harm associated with intraoperative bleeding
• Class ICompleted2019-04-11
  The staplers may have an insufficient firing stroke to break the washer and completely form staples.
• Class IITerminated2018-12-07
  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
• Class IITerminated2018-05-03
  The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
• Class IITerminated2018-03-26
  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.
• Class IITerminated2017-10-23
  There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.
• Class IITerminated2017-03-31
  There is a risk that the pinion gear in the device could fail under extreme use cases.
• Class IITerminated2016-07-15
  Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted
• Class IITerminated2015-09-23
  Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
• Class ITerminated2015-05-13
  Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit.
• Class IITerminated2015-02-26
  During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.
• Class IITerminated2014-08-12
  The device may have a non-conforming component that may cause the device to fire an unformed staple.
• Class IITerminated2013-09-30
  During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
• Class IITerminated2013-05-13
  Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence.
• Class IITerminated2013-04-12
  Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel
• Class IITerminated2013-04-08
  The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device.
• Class IITerminated2012-11-06
  Potential for self activation while the device is in use, which may result in unintended thermal damage.
• Class IITerminated2012-10-04
  Damage to the packaging may have compromised the sterility of the device.
• Class ITerminated2012-08-03
  Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and Transtar¿ Circular Stapler Procedure Set (STR10) due to difficulty firing the device which may resul

Related

• All facilities operated by ETHICON ENDO-SURGERY, INC.
• ETHICON ENDO-SURGERY, INC. (OH)

Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-15. Verify this facility record at FDA →