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 Policot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling 39 boxes of Uniqcot sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 103 boxes of Americot Blue 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 38 boxes distributed worldwide.
American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall covers 24 boxes distributed worldwide.
American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall affects worldwide distribution.
American Surgical Company is recalling 11 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling Policot sponges because defective packaging compromises sterility. The products were distributed worldwide.
American Surgical Company is recalling 315 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers 6 boxes distributed worldwide.
American Surgical Company is recalling 182 boxes of strung cotton balls due to packaging defects that compromise sterility.
American Surgical Company is recalling specific lots of strung cotton balls because defective packaging may compromise sterility.
American Surgical Company is recalling 33 boxes of Delicot-J sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 449 boxes of Ray-Cot sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 15 boxes of Ultracot sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Delicot X sponges due to packaging defects that compromise sterility. The recall covers 3 boxes distributed worldwide.
American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall affects 262 boxes distributed worldwide.
American Surgical Company is recalling 7 boxes of Uniqcot sponges because defective packaging may compromise sterility. The product was distributed worldwide.
American Surgical Company is recalling Delicot X sponges because defective packaging may compromise sterility. The recall affects worldwide distribution.
American Surgical Company is recalling 442 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling Delicot non-xray sponges because defective packaging compromises sterility. The recall covers 4 boxes distributed worldwide.
American Surgical Company is recalling Telfa neurosurgical sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 113 boxes of Delicot 6 mm x 50 mm sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Telfa sponges because defective packaging may compromise sterility. The affected lot is distributed worldwide.
American Surgical Company is recalling 37 boxes of Delicot-J sponges because defective packaging compromises sterility. The products were distributed worldwide.