FDA (Devices) recall action 73734
The FDA (Devices) publishes a recall like this one as 91 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 91 pages.
Product packaging defective compromising sterility
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.
American Surgical Company is recalling Telfa sponges because defective packaging may compromise sterility. The recall covers 178 boxes distributed worldwide.
American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall covers 78 boxes distributed worldwide.
American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers 155 boxes distributed worldwide.
American Surgical Company is recalling 41 boxes of Ultracot sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 165 boxes distributed worldwide.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers three boxes distributed worldwide.
American Surgical Company is recalling 22 boxes of Americot Blue sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 33 boxes of Ultracot sponges because defective packaging may compromise sterility. The affected products were distributed worldwide.
American Surgical Company is recalling 15 boxes of Americot Blue sponges because defective packaging compromises sterility.
American Surgical Company is recalling Delicot sponges because defective packaging may compromise sterility. The recall covers 343 boxes distributed worldwide.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 209 boxes distributed worldwide.
American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 3 boxes distributed worldwide.
American Surgical Company is recalling 37 boxes of Americot Blue sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling 27 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 27 boxes distributed worldwide.
American Surgical Company is recalling Americot White sponges because defective packaging may compromise sterility. The recall covers 35 boxes distributed worldwide.
American Surgical Company is recalling 21 boxes of Delicot non-xray sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 97 boxes of Delicot 5 mm x 13 mm sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Policot sponges because defective packaging may compromise sterility. The recall covers 3 boxes distributed worldwide.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 16 boxes distributed worldwide.
American Surgical Company is recalling 39 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 4 cases distributed worldwide.
American Surgical Company is recalling 32 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall affects 4 boxes distributed worldwide.
American Surgical Company is recalling 99 units of Delicot 4 mm x 50 mm sponges because defective packaging may compromise sterility.