FDA (Devices) recall action 85022
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.
Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
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.
Medline Industries is recalling 3,690 units of sterile 3mL syringes because voids in the packaging seal caused a loss of sterility.
Medline is recalling Stick Sponge Presaturated W/PVP units due to packaging seal voids that compromise sterility.
Medline Industries is recalling 117,874 units of Winged Sponges Presaturated W/PVP because voids in the packaging seal caused a loss of sterility.