Ethicon Endo-Surgery Recalls

Hazard: 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

Hazard: 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

Hazard: The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

Hazard: The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.

Hazard: There is a risk that the pinion gear in the device could fail under extreme use cases.

Hazard: 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 and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.

Hazard: 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 and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.

Hazard: Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.

Hazard: 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.

Hazard: During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.

Hazard: The device may have a non-conforming component that may cause the device to fire an unformed staple.

Hazard: During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.

Hazard: During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.

Hazard: During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.

Hazard: 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 or other structure

Hazard: 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 or other structure

Hazard: 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 or other structure

Hazard: 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.

Hazard: 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.

Hazard: Damage to the packaging may have compromised the sterility of the device.

Hazard: Potential for self activation while the device is in use, which may result in unintended thermal damage.

Hazard: 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 result in incomplete firing stroke that may result in an incomplete staple formation.