FDA (Devices) recall action 82950
The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
The FDA is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
The FDA is recalling 3,113,280 units of the EGIA 45 Articulating Xtra Thick Sulu device due to a missing pin component that may cause incomplete staple formation and serious medical complications.
The FDA is recalling 3,113,280 units of the EGIA 60 Articulating Extra Thick Sulu device due to a missing pin component that may cause incomplete staple formation and serious surgical complications.
FDA is recalling 3,113,280 units of the EGIA 60 Articulating Medical Stapler due to missing pin components that may cause incomplete staple formation and serious surgical complications.
The FDA is recalling 3,113,280 units of EGIA45 CT AR MD THK REL surgical staplers because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
Covidien LLC is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, potentially leading to serious surgical complications.
The FDA is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
Covidien LLC is recalling Signia Tri-Staple 2.0 reloads because missing pin components may cause incomplete staple formation, potentially leading to serious surgical complications.
FDA is recalling 3.1 million EGIA 45 staplers due to missing pins that may cause incomplete stapling and serious surgical complications.
The FDA is recalling 3,113,280 units of the EGIA 30 Articulating Medical device due to missing pin components that may cause incomplete staple formation and serious surgical complications.
FDA is recalling 3,113,280 units of the EGIA 60 Curved Tip Art Med Thick Sulu surgical stapler because missing pin components may cause incomplete staple formation and serious medical complications.
Covidien LLC is recalling Signia Tri-Staple 2.0 reloads because missing pin components may cause incomplete staple formation, leading to serious surgical complications.