Z-0413-2022Class II

Torosa Saline-Filled Testicular Prosthesis (Size Small)

Name: Z-0413-2022 Torosa Saline-Filled Testicular Prosthesis (Size Small)
Creator: Coloplast Manufacturing US, LLC
Published: 2021-11-09
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2021-11-09 / Terminated / root cause: manufacturing process

FDA source

Coloplast Manufacturing US, LLC began a recall of Torosa Saline-Filled Testicular Prosthesis (Size Small) on 2021-11-09. FDA classified it as Class II and gives the reason as "Product is mislabeled for size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0413-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-09
Posted: 2021-12-22
Terminated: 2025-09-29
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Torosa Saline-Filled Testicular Prosthesis (Size Small)
Product code: FHW Device, Impotence, Mechanical/Hydraulic
Reason for recall: Product is mislabeled for size.
Root cause tag: manufacturing process
FDA 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 in commerce: 19 units
Distribution: Worldwide distribution - US Nationwide distribution and the country of Canada.
Product codes and lots: SKU# 5206102400; Catalo # (450-1325); Lot 7685283

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0413-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0413-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-29	2021-12-22

Product code FHW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)