FDA (Devices) recall action 80401
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.
Products do not meet a tensile strength specification
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, Inc. is recalling 72 units of PDS II sutures because they do not meet tensile strength specifications.
Ethicon, Inc. is recalling 756 units of PDS Plus Antibacterial Sutures because they do not meet tensile strength specifications. The affected products were distributed in Japan.
Ethicon, Inc. is recalling specific lots of PDS Plus Antibacterial Sutures because they do not meet tensile strength specifications.