Ethicon Endo-Surgery HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm recall — FDA Z-2049-2018
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
Overview of recall records associated with Ethicon Endo-Surgery Inc., including dates, categories and classifications where available.
Classification mix: Class I: 17, Class II: 16.
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
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…
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…
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…
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…
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…
There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.
There is a risk that the pinion gear in the device could fail under extreme use cases.
This page summarizes recall records in which the official source identifies Ethicon Endo-Surgery Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.