FDA (Devices) recall action 98312
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
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.
Aju Pharm is recalling 416 units of the AlternatiV+ Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Aju Pharm is recalling 200 units of the Genesis Push-In Suture Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Weaver's Brew is recalling 1,014 cases of Goldenroot Lemon Ginger Hibiscus Ginger Beer because the products might contain ginger juice that did not undergo the required pasteurization process.
Aju Pharm is recalling 1,088 units of the Fixone Biocomposite Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Prima Vera Nueva is recalling 16,790 packages (4 tamales per package) of Black Bean Bonanza Tamales with Black Beans over potential contamination with Listeria monocytogenes.
Aju Pharm is recalling 2,569 AlternatiV+ Max Knotless Anchors after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Aju Pharm is recalling 600 units of the Genesis Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.
Bharat Bazar is recalling 180 packages of Soma Kitchen Natural Asafoetida over undeclared wheat.