FDA (Devices) recall action 88656
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.
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
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.
Stradis Medical recalled 14,959 IUD Insertion Kits nationwide after being unable to confirm the tenaculum devices were manufactured according to required design and manufacturing standards.
Stradis Healthcare is recalling its Standard IUD Insertion Kit (280 units) after being unable to confirm the tenaculum devices meet required design and manufacturing standards.
Stradis Medical recalled 790 Foundation Kits because the manufacturer cannot confirm tenaculum devices met design and manufacturing standards.
Stradis Medical recalls IUD Insertion Packs because the firm cannot confirm tenaculum devices met required design and manufacturing standards. The recall affects 20 kits distributed nationwide.
Stradis Medical is recalling plastic tenaculum surgical instruments because the manufacturer cannot confirm they were produced in accordance with required design and manufacturing standards. Approximately 2,483 kits were distributed nationwide and to Canada.
Stradis Medical is recalling 1,639 Endometrial Biopsy Kits nationwide because the manufacturer cannot confirm the tenaculum devices meet required design and manufacturing standards.