FDA (Devices) recall action 77842
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.
Potential for partially incomplete seal of product, impacting sterility.
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.
Epimed International is recalling 500 units of RX-2 COUDE Epidural Needles due to a potential incomplete seal that may impact sterility.
Epimed International is recalling COUDE Blunt Nerve Block Needles due to a potential seal defect that may compromise sterility.
Epimed International is recalling 263 units of TUOHY Epidural Needles because a partially incomplete seal could impact the product's sterility.