FDA (Devices) recall action 67147
The FDA (Devices) publishes a recall like this one as 28 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 28 pages.
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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.
Synergetics Inc is recalling 25ga Mid-Field Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising sterility.
Synergetics Inc is recalling 108 units of 23ga Wide Field Corona Endo Illuminators because faulty seals on the outer pouch could result in seal failure.
Synergetics Inc is recalling 96 units of 25ga Wide Field Corona Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.