Recall Z-0413-2022— Coloplast Manufacturing US, LLC
Class II · Terminated
Class II FDA medical device recall by Coloplast Manufacturing US, LLC, initiated 2021-11-09, terminated 2025-09-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Torosa Saline-Filled Testicular Prosthesis (Size Small). Reason: Product is mislabeled for size..
- Recalling firm
- Coloplast Manufacturing US, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-09
- Terminated
- 2025-09-29
- Firm location
- Minneapolis, MN, United States
Product description
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Reason for recall
Product is mislabeled for size.
Data sourced from openFDA. This site is unofficial and independent of the FDA.