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 specific lots of strung cotton balls because defective packaging may compromise sterility.
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 22 boxes of Americot Blue sponges because defective packaging may compromise sterility.
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 13 boxes of strung cotton balls due to packaging defects that compromise sterility.
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 Delicot X sponges due to packaging defects that compromise sterility. The recall covers 3 boxes distributed worldwide.
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 35 boxes of Americot Blue sponges because defective packaging may compromise sterility.
American Surgical Company is recalling 39 boxes of Uniqcot sponges because defective packaging may compromise sterility.
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 Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 38 boxes distributed worldwide.
American Surgical Company is recalling Telfa sponges because defective packaging may compromise sterility. The affected lot is distributed worldwide.
American Surgical Company is recalling 70 units of strung cotton balls 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 Telfa neurosurgical and nonneurosurgical sponges because defective packaging may compromise sterility.
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall affects 266 boxes 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 Delicot X sponges because defective packaging may compromise sterility. The recall affects worldwide distribution.
American Surgical Company is recalling Telfa 1" x 1" neurosurgical and nonneurosurgical sponges because defective packaging compromises sterility.
American Surgical Company is recalling 15 boxes of Americot Blue sponges because defective packaging compromises sterility.
American Surgical Company is recalling 33 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 may compromise sterility. The recall covers two boxes distributed worldwide.
American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall covers 24 boxes distributed worldwide.