The FDA has posted 7 enforcement recalls of inflatable penis prosthesis devices since 2025, none of them Class I (most serious). Most recent report: Oct 22, 2025.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Prosthesis, Penis, Inflatable”). Informational only — verify against the FDA before acting.