FDA (Devices) recall action 73382
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.
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
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.
Ossur H / F is recalling Lil Angel Vest P3 Sorbatex units because the plastic stabilizer strap may partially or completely fracture.
Ossur H / F is recalling Lil Angel Vest P2 Sorbatex pediatric vests because the plastic stabilizer strap may partially or completely fracture.
Ossur H / F is recalling Lil Angel Vest P3 Kodel units due to a potential for partial or complete fracture of the plastic stabilizer strap.
Ossur H / F is recalling Lil Angel Vest P2 Lambswool units because the plastic stabilizer strap may partially or completely fracture.
Ossur H / F is recalling 435 Lil Angel Vest P2 Kodel units due to a potential for partial or complete fracture of the plastic stabilizer strap.
Ossur H / F is recalling Lil Angel Vest P3 Lambswool units because the plastic stabilizer strap may fracture. The recall covers 435 units distributed in the US and Hong Kong.