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 34 boxes of strung cotton balls due to packaging defects that compromise sterility. The products were distributed worldwide.
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 39 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
American Surgical Company is recalling 87 boxes of strung cotton balls due to packaging defects that compromise sterility.
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 Americot Blue sponges because defective packaging may compromise sterility. The recall covers 37 boxes distributed worldwide.
American Surgical Company is recalling Telfa 1" x 3" sponges because defective packaging compromises sterility. The recall covers 57 boxes distributed worldwide.
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 68 boxes of Delicot-J sponges because defective packaging compromises sterility. The products were distributed worldwide.
American Surgical Company is recalling 351 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
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 11 boxes of cylindrical sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 15 cases distributed worldwide.
American Surgical Company is recalling Policot sponges because defective packaging compromises sterility. The products were distributed worldwide.
American Surgical Company is recalling Telfa 1/2" x 1/2" sponges because defective packaging may compromise sterility. The recall covers 24 boxes 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 Policot 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 41 boxes of Ultracot sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may have compromised sterility. The recall covers 28 boxes distributed worldwide.
American Surgical Company is recalling 3 boxes of 1-inch non-strung cotton balls due to packaging defects that compromise sterility.
American Surgical Company is recalling 102 boxes of Ray-Cot 1" x 1" sponges because defective packaging compromises sterility.
American Surgical Company is recalling 237 units of 1-inch strung cotton balls due to packaging defects that compromise sterility.
American Surgical Company is recalling 114 cases of Ultracot sponges because defective packaging compromises sterility.
American Surgical Company is recalling 21 boxes of Delicot non-xray sponges because defective packaging may compromise sterility.