Coloplast Manufacturing US, LLC Torosa Saline-Filled Testicular Prosthesis (Size Small) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Brand
Coloplast Manufacturing US, LLC
Lot Codes / Batch Numbers
SKU# 5206102400, Catalo # (450-1325), Lot 7685283
Products Sold
SKU# 5206102400; Catalo # (450-1325); Lot 7685283
Coloplast Manufacturing US, LLC is recalling Torosa Saline-Filled Testicular Prosthesis (Size Small) due to Product is mislabeled for size.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product is mislabeled for size.
Recommended Action
Per FDA guidance
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.
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