FDAClass IIDecember 29, 2021

Torosa Saline-Filled Testicular Prosthesis recall: Labeling Error

Torosa Saline-Filled Testicular Prosthesis (Size Small)

Why was Torosa Saline-Filled Testicular Prosthesis recalled?

Product is mislabeled for size.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

SKU# 5206102400; Catalo # (450-1325); Lot 7685283

Product
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Recalling firm
Coloplast Manufacturing US, LLC
Quantity
19 units
Distribution
Worldwide distribution - US Nationwide distribution and the country of Canada.
Recall date
December 29, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls