FDA (Devices) recall action 93395
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
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 1,800 units of Sterile Betadine (Ref DYNDA1998) because the foil sachet contents are non-sterile, despite labeling that claims sterility. The recall affects units nationwide in eight states.
Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.
Medline PVP Solution (REF DYNDA1858) is being recalled because it is labeled as sterile but contains non-sterile contents. 1,950 units are affected.
Medline Industries is recalling 8,250 units of sterile PVP solution distributed nationwide because the contents are non-sterile despite being labeled as sterile.
Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.
Medline Industries is recalling sterile prep sticks (REF DYNDA1134) labeled as sterile that contain non-sterile solution, posing infection risk in medical procedures.
Medline STERILE PVP SLN KIT (Lot 21GBJ087) is recalled because its contents are non-sterile despite labeling stating sterile product. Consumers should stop use immediately.