FDA (Devices) recall action 82973
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Observed reported incidence rate for harm associated with intraoperative bleeding
Observed reported incidence rate for harm associated with intraoperative bleeding
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.
Ethicon is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to a reported incidence of intraoperative bleeding.
Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.
Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.