FDA (Devices) recall action 79656
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
The agency’s own wording, quoted from the enforcement report.
Aesculap Implant Systems LLC is recalling Strauss Penis Clamps because plastic sleeves may stick together, rendering the instruments unusable.
Aesculap Implant Systems LLC is recalling Doyen-Collin Mouth Gags because plastic sleeves may stick together, rendering the instruments unusable.