FDA (Devices) recall action 97507
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
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.
Aesculap is recalling three ELAN 4 Fixed Duraguard Long units after the Standard version was labeled as "Long" and the Long version was labeled as "Standard".
Aesculap is recalling one ELAN 4 Fixed Duraguard unit after the Standard version was labeled as "Long" and the Long version was labeled as "Standard".