Coloplast Manufacturing US, LLC Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
Brand
Coloplast Manufacturing US, LLC
Lot Codes / Batch Numbers
UDI/DI 05708932487382, Lot Numbers: 8849602, 8904182, 8840688, 8849622
Products Sold
UDI/DI 05708932487382, Lot Numbers: 8849602, 8904182, 8840688, 8849622
Coloplast Manufacturing US, LLC is recalling Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis due to A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
Recommended Action
Per FDA guidance
The firm issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice on 03/01/2023 by UPS next day air. The notice explained the issue and the hazard to health. The notice requests the removal and return of the affected product. Distributors are instructed to notify their customers. For further questions, please contact the Coloplast Customer Service team directly at (800) 258-3476, or by email urology@coloplast.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026