Coloplast Manufacturing US LLC
United Statesfrom the FDA registration address FDA establishment FEI 3032906574
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 3420 ongoing
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Regimes: 510(k) Registry: 510(k)
Self Cath Catheter Ref K100878
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Virtue Ventral Urethral Elevation Sling System Ref K082640
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3032906574
- Address
- 680 E Travelers Trl Ste 800, Burnsville, MN, 55337
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 1
- 2021 1
- 2022 0
- 2023 17
- 2024 3
- 2025 0
- 2026 0
2024
- 2 Dec 2024 Z-0844-2025 Class II Ongoing A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
- 2 Dec 2024 Z-0845-2025 Class II Ongoing A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
- 11 Mar 2024 Z-1463-2024 Class II Ongoing 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.
2023
- 1 Mar 2023 Z-1359-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1360-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1361-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1362-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1363-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1364-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1365-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1359-2023 Class II Ongoing 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.
Show the 25 most recent of 34 recalls
2023
- 1 Mar 2023 Z-1366-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1367-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1368-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1369-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1370-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1371-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1372-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1373-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1374-2023 Class II Ongoing XXX
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- 1 Mar 2023 Z-1375-2023 Class II Ongoing 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.
Full distribution text
- 1 Mar 2023 Z-1366-2023 Class II Ongoing 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.
2021
- 9 Nov 2021 Z-0413-2022 Class II Terminated Product is mislabeled for size.
2020
- 23 Oct 2020 Z-0488-2021 Class II Terminated Potential increased occurrence of pump fracture over the lifetime of the device.
Full distribution text
- 23 Oct 2020 Z-0488-2021 Class II Terminated Potential increased occurrence of pump fracture over the lifetime of the device.
2016
- 22 Mar 2016 Z-1525-2016 Class II Terminated Coloplast Corp. is voluntarily recalling a single lot of Self-Cath Pediatric French Size CH 06 catheters
because a small portion of the lot was identified to have missing eyelets. This recall is based upon a
complaint Coloplast received regarding a catheter malfunction.
Full distribution text
- 22 Mar 2016 Z-1525-2016 Class II Terminated Coloplast Corp. is voluntarily recalling a single lot of Self-Cath Pediatric French Size CH 06 catheters
because a small portion of the lot was identified to have missing eyelets. This recall is based upon a
complaint Coloplast received regarding a catheter malfunction.
2015
- 9 Apr 2015 Z-1538-2015 Class II Terminated Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The device size is printed directly on the individual prosthesis tray during the packaging process and states the correct size, 9.5 mm.
2014
- 29 Sep 2014 Z-0155-2015 Class II Terminated Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
Full distribution text
- 29 Sep 2014 Z-0155-2015 Class II Terminated Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
Frequently asked questions
How many devices does Coloplast Manufacturing US LLC have in the registry?
The registry currently lists 4 devices for Coloplast Manufacturing US LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Coloplast Manufacturing US LLC's devices?
Among its 4 most recently registered devices, Coloplast Manufacturing US LLC has devices listed in FDA 510(k) (4 devices).
What risk classes do Coloplast Manufacturing US LLC's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Coloplast Manufacturing US LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Coloplast Manufacturing US LLC?
FDA recall records list 34 recalls initiated by Coloplast Manufacturing US LLC, the most recent initiated on 2 Dec 2024. 20 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Coloplast Manufacturing US LLC in the registry?
The most recently registered devices listed for Coloplast Manufacturing US LLC include DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE, SELF CATH CATHETER, SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM and VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM.