FDA (Devices) recall action 64531
The FDA (Devices) publishes a recall like this one as 9 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 9 pages.
Pessary mislabeled outer package may not reflect the size of the product contained in the package
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.
Cooper Surgical is recalling 70 units of Cube Pessaries because the outer packaging may not reflect the actual size of the product inside.
Cooper Surgical is recalling Incontinence Dish Folding Pessaries because the outer package may not reflect the actual product size.
Cooper Surgical is recalling 20 units of Cube Pessaries because the outer packaging may not reflect the actual product size.
Cooper Surgical is recalling 45 units of Incontinence Dish pessaries because the outer package may not reflect the actual product size.
Cooper Surgical is recalling 31 units of Incontinence Dish Folding Pessaries because the outer packaging may not reflect the actual product size.
Cooper Surgical is recalling Gellhorn Flexible Pessaries because the outer packaging may not accurately reflect the size of the product inside.
Cooper Surgical is recalling 18 units of Incontinence Dish pessaries because the outer package may not reflect the actual product size.
Cooper Surgical is recalling 80 units of Incontinence Ring Flexible Pessaries because the outer packaging may not reflect the actual product size.
Cooper Surgical is recalling Gellhorn Flexible Pessaries because the outer packaging may not reflect the actual size of the device inside.