Lower riskMedical device recall · FDA · Published November 9, 2021
Coloplast Torosa Saline-Filled Testicular Prosthesis Size Small Mislabeling Recall
Coloplast recalls small saline-filled testicular prosthesis units due to size mislabeling. Affected units may not fit properly, but no injury risk is reported.
“Coloplast Torosa Saline-Filled Testicular Prosthesis Size Small Mislabeling Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61554-coloplast-torosa-saline-filled-testicular-prosthesis-size-small-mislabeling-recall. Based on FDA recall #Z-0413-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0413-2022%22&limit=1).
The FDA announced on Nov. 9, 2021, that Coloplast Manufacturing US, LLC is recalling Torosa Saline-Filled Testicular Prosthesis (Size Small) due to mislabeling. The agency issued recall number Z-0413-2022 for the Class II device.
The product is mislabeled for size, according to the FDA. The recall affects 19 units distributed nationwide in the U.S. and in Canada.
Context
GovInfoNow's records show Coloplast Manufacturing US, LLC has had four other recalls since Oct. 23, 2020. Recent issues include a Dec. 2, 2024, sterility concern with X-Flow Prostatectomy Catheters and a March 11, 2024, packaging issue with Ureteral Dilators. Other recent recalls of similar products include W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis (May 22, 2026) and Howmedica Triathlon Baseplate Size 3 (May 19, 2026).
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.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.