FDA Medical Device Recalls (openFDA)
Coloplast Manufacturing US, LLC: Torosa Saline-Filled Testicular Prosthesis (Size Small)
- Recall number
- Z-0413-2022
- Recalling firm
- Coloplast Manufacturing US, LLC
- Product
- Torosa Saline-Filled Testicular Prosthesis (Size Small)
- Status
- Terminated
- Initiated
- 2021-11-09
- Posted
- not on file
- Terminated
- 2025-09-29
- Reason
- Product is mislabeled for size.
- Root cause
- Process control
- Action
- A customer letter was issued to affected consignees dated 11/09/2021. Consignees are asked to move all inventory to quarantine and returned all impacted product within 10 days of letter receipt. If the product was further distributed, the consignee is directed to notify downstream customers of the recall. An Acknowledgement and Receipt Form should be completed indicating the quantity that will be returned. This should be completed even if there is no inventory.
- Quantity
- 19 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Canada.
- Lot, serial or model codes
- SKU# 5206102400; Catalo # (450-1325); Lot 7685283
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- 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