The Recall Desk
HighFDA (Devices)·Z-0844-2025·Announced 2025-01-22

Folysil Silicone Foley Catheters Recalled for Possible Sterility Issue

Coloplast recalls Folysil Silicone Foley Catheters due to a possible sterility defect detected at the manufacturing facility. The affected units may not maintain proper sterilization, posing a risk of infection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving a potential sterility defect in catheters used in direct contact with internal tissue. No illnesses or injuries have been reported in the source, but the hazard presents a risk-of-harm product where injury has not yet been reported, qualifying as a High severity recall.

Plain-English summary

Coloplast Manufacturing US, LLC has issued a recall of Folysil Silicone Foley Catheters in various sizes and device reference numbers. The recall affects 226,452 units distributed nationwide in the United States and in Canada.

The recall was initiated due to a possible sterility issue detected at Coloplast's manufacturing facility. Affected catheters may not maintain proper sterilization, creating a potential risk of infection when used.

Healthcare providers and patients currently using affected catheters should contact Coloplast or their healthcare provider for guidance. The manufacturer can provide information on replacement products and answer questions about the recall.

The recalled product

Product
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, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA642
Manufacturer
Coloplast Manufacturing US, LLC
Category
Medical Device — Catheter / Urinary Device
Hazard
Affected units
226,452

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Device Reference Number AA6106
  • GTIN 3600040126851
  • Lot Numbers 7278611
  • 7326825
  • 7469914
  • 7528770
  • 7540052
  • 7616917
  • 7680676
  • 7726724
  • 7748128
  • 7794789
  • 7874610
  • 7883406
  • 7948568
  • 7987184
  • 7987186
  • 7998885
  • 8097945
  • 8097947

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Coloplast Manufacturing US, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Coloplast Manufacturing US, LLC

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Same hazard · sterility defect

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