Minneapolis, MN, United States
Coloplast Manufacturing US, LLC recalls
5 recalls recorded since 2018, most recently on 2 December 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)3
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 December 2024
- Reason
- A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
- Distribution
- US Nationwide. Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0845-2025, Z-0844-2025
- X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A
- Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, A
Ongoing Class II Medical devices
- Recall started
- 11 March 2024
- Reason
- A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
- Distribution
- US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1463-2024
- Ureteral dilator, REF RBD014
Ongoing Class II Medical devices
- Recall started
- 1 March 2023
- Reason
- A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1360-2023, Z-1366-2023, Z-1364-2023, Z-1371-2023, Z-1370-2023, Z-1369-2023, Z-1367-2023, Z-1363-2023, Z-1374-2023, Z-1361-2023, Z-1372-2023, Z-1368-2023 and 5 more
- Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
- Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
- Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
- Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
- Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- and 9 more product lines
Terminated Class II Medical devices
- Recall started
- 9 November 2021
- Terminated
- 29 September 2025
- Reason
- Product is mislabeled for size.
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0413-2022
- Torosa Saline-Filled Testicular Prosthesis (Size Small)
Terminated Class II Medical devices
- Recall started
- 23 October 2020
- Terminated
- 13 May 2021
- Reason
- Potential increased occurrence of pump fracture over the lifetime of the device.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of DK, ES, JP.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0488-2021
- Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.