Coloplast Torosa Saline-Filled Testicular Prosthesis Size Small Mislabeling Recall

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Contact the company & request your remedy

Recalling firmColoplast Manufacturing US, LLC1601 W River Rd, N/A · Minneapolis, MN 55411-3431

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Coloplast is recalling small saline-filled testicular prosthesis units because they are mislabeled for size. This could cause improper fitting, but the recall does not mention any injury risk.

Why it’s dangerous

The product is mislabeled for size, which could lead to improper fitting. However, the recall does not indicate any risk of injury or harm to users.

Who’s affected

Individuals who own or use the Coloplast Torosa Sal: Size Small saline-filled testicular prosthesis units. Men with this specific prosthesis are most at risk of improper fitting.

How to tell if you have this one

Check for the product name 'Torosa Saline-Filled Testicular Prosthesis (Size Small)', SKU# 5206102400, Catalo # (450-1325), or Lot 7685283 on the packaging or label.

Brand
Coloplast
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the product name, SKU, Catalo number, and Lot number on the packaging or label to confirm if it is affected.

✎ GovInfoNow

Questions people ask

Is there a risk of injury from this mislabeling?

The recall does not mention any injury risk, so there is no reported risk of harm.

How can I tell if my prosthesis is affected?

Check for the product name 'Torosa Saline-Filled Testicular Prosthesis (Size Small)', SKU# 5206102400, Catalo # (450-1325), or Lot 7685283 on the packaging or label.

Do I need to return this product?

The recall does not specify a return or remedy, so no action is required beyond checking the label.

Take action

Contact Coloplast

We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0413-2022 — Coloplast Coloplast

Hello,

I own a Coloplast that is covered by recall Z-0413-2022 from Coloplast.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0413-2022 (November 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0413-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Coloplast Manufacturing US, LLC recalls Torosa Saline-Filled Testicular Prosthesis (Size Small)

Lower-risk recall