FDA (Devices) recall action 97480
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Labeling includes shelf life that has not been validated.
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.
Frontier Devices 14 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated.
Frontier Devices 12 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 3,790 units are affected.
Frontier Devices 14 mm Distraction Pins in 5 single packs are recalled because the labeling includes a shelf life that has not been validated. 2,700 units are affected.
Frontier Devices 14 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 10,960 units are affected.
Frontier Devices 12 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated. 160 units are affected.
Frontier Devices 16 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 490 units are affected.