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Coloplast Manufacturing US, LLC

Coloplast Manufacturing US, LLC Recalls

All product recalls associated with Coloplast Manufacturing US, LLC.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Dec 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–25 of 25 recalls

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

Product is mislabeled for size.

FDANov 9, 2021Nationwide• Coloplast Manufacturing US, LLC

Coloplast Manufacturing US, LLC: Titan Pump - Product Usage: indicated for male patients s...

Potential increased occurrence of pump fracture over the lifetime of the device.

FDAOct 23, 2020Nationwide• Coloplast Manufacturing US, LLC

Coloplast Manufacturing US, LLC: Coloplast Conveen Urine Collection Leg Bag, Product Numbe...

Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.

Class IIModerate

FDA

Page 2 of 2Next

Sep 29, 2014

Nationwide

• Coloplast Manufacturing US, LLC

Coloplast Manufacturing US, LLC: Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs,...

Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.

Class IIILow

FDASep 8, 2014MO, RI• Coloplast Manufacturing US, LLC

Coloplast Manufacturing US, LLC: Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scr...

Coloplast determined that a portion of Titan OTR pumps were manufactured using a process that where validation activities were not completed. The Titan OTR pumps were made to our standard product specifications and have passed all in-process testing to ensure mechanical reliability of these pumps. Coloplast is not recommending product explant because there are no identified risks since the prod

FDAOct 6, 2009Nationwide• Coloplast Manufacturing US, LLC