Coloplast Manufacturing US, LLC 2025-01-22 Health serious FDA
Health · FDA · Recall #FDA-Z-0845-2025
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120,… Recall
Issued January 22, 2025 · Coloplast Manufacturing US, LLC
In January 2025, Coloplast Manufacturing US, LLC recalled the X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
What you should do
- 1 Stop using X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Coloplast Manufacturing US, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Coloplast Manufacturing US, LLC
- Category
- Health
- Recall date
- January 22, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide. Canada.
- Recall number
- FDA-Z-0845-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Coloplast Manufacturing US, LLC has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.