Coloplast Manufacturing recalls
5 official recalls and safety alerts involving Coloplast Manufacturing since 2021-12, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Coloplast Manufacturing or the relevant agency.
- 2025-01-22
USColoplast Manufacturing US, LLC recalls X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224,…
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
- 2024-04-10
- US
Coloplast Manufacturing US, LLC recalls Ureteral dilator, REF RBD014
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…
- 2023-04-19
- US
Coloplast Manufacturing US, LLC recalls Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
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FDA · DeviceColoplast Manufacturing US, LLCWorldwide distribution - US Nationwide and the countries of Turkey, Italy,…Official notice → - US
Coloplast Manufacturing US, LLC recalls Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
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…
FDA · DeviceColoplast Manufacturing US, LLCWorldwide distribution - US Nationwide and the countries of Turkey, Italy,…Official notice → - 2021-12-29
- US
Coloplast Manufacturing US, LLC recalls Torosa Saline-Filled Testicular Prosthesis (Size Small)
Product is mislabeled for size.
FDA · DeviceColoplast Manufacturing US, LLCWorldwide distribution - US Nationwide distribution and the country of Canada.Official notice →