FDA Medical Device Recalls (openFDA)
Coloplast Manufacturing US, LLC: Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
- Recall number
- Z-1374-2023
- Recalling firm
- Coloplast Manufacturing US, LLC
- Product
- Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
- Status
- Open, Classified
- Initiated
- 2023-03-01
- Posted
- 2023-04-12
- Terminated
- not on file
- Reason
- XXX
- Root cause
- Process change control
- Action
- 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.
- Quantity
- 20 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
- Lot, serial or model codes
- UDI/DI 05708932487368, Lot Numbers: 8849601, 8849600, 8849621
- 510(k) numbers
- not on file
- PMA numbers
- ["P000006"]
- Product code
- FHW
- Firm FEI
- 2125050
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28