Testicular Prosthesis Recalled Due to Incorrect Size Labeling
Coloplast Manufacturing is recalling Torosa Saline-Filled Testicular Prosthesis (Size Small) due to incorrect size labeling. Nineteen units were distributed in the US and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall involving a labeling error on a medical device. No illnesses or injuries are reported. The hazard is limited to size mislabeling, classified as a minor labeling error.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling Torosa Saline-Filled Testicular Prosthesis (Size Small) because the product is mislabeled for size. Nineteen units were affected by this labeling error.
The recalled product was distributed worldwide, including throughout the United States and Canada. The affected lot is numbered 7685283 (SKU# 5206102400; Catalog # 450-1325).
The recalled product
- Product
- Torosa Saline-Filled Testicular Prosthesis (Size Small)
- Manufacturer
- Coloplast Manufacturing US, LLC
- Hazard
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- SKU# 5206102400
- Catalo # (450-1325)
- Lot 7685283
Distribution
Distributed nationwide across the United States.
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