External Penile Rigidity Devices

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 5/19/2023 updates the reason for alert and guidance section, product description section, and charge code language. Changes to the import alert are bracketed by asterisks (***). The use of external penile rigidity devices may have harmful effects such as, aggravating existing medical conditions such as Peyronie's disease, priapism, and urethral stricture. They may injure or cause rupture of the subcutaneous blood vessels, which may produce hemorrhage and hematoma formation. Additionally, frequent use of erection maintaining rings may result in ***discoloration of the skin, typically caused by bruising*** of the proximal portion of the penis and scrotum, and the lymphatic stasis of the penis. Prolonged use of the rings may cause gangrene of the penis. These devices generally fall into the following categories and these products should fol

Quoted from the “Reason for Alert” section of the FDA page for 78-01, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.