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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Coloplast Manufacturing US, LLC
- 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
See all →- HighX-Flow Prostatectomy Catheter Recalled for Possible Sterility Defect
FDA (Devices) · 2025-01-22
- HighColoplast Ureteral Dilators Recalled Due to Sterile Packaging Issue
FDA (Devices) · 2024-04-10
- HighInflatable Penile Prosthesis Risk of Premature Pump Failure
FDA (Devices) · 2023-04-19
- HighInflatable penile prosthesis recalled due to pump wall thickness manufacturing defect
FDA (Devices) · 2023-04-19
- ModerateInflatable Penile Prosthesis Titan Recalled Coloplast Manufacturing Class II
FDA (Devices) · 2023-04-19
Same hazard · sterility defect
See all →- SevereLidocaine Hydrochloride Injection Recalled for Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereIMULDOSA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-08
- HighChloraPrep One-Step antiseptic solution sterility assurance recall
FDA (Drugs) · 2026-07-01
- ModerateCodman CerebroFlo EVD Catheter recalled for out-of-specification endotoxin
FDA (Devices) · 2026-05-20
- SevereGenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
Similar recalls
- SevereCustomed Recalls Foley Catheter Kits Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- SevereCustomed Foley Catheter Kit Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- SevereCustomed Recalls Foley Catheter Kits Due to Potential Packaging Integrity Issues
FDA (Devices) · 2014-09-10
- SevereCustomed Foley Catheter Kit Recalled for Compromised Sterility
FDA (Devices) · 2014-12-10
- ModerateHydroSil Go Catheters Recalled for Packaging Sterility Risk
FDA (Devices) · 2023-06-14
- HighC.R. Bard Foley Catheter Tray recalled for potential packaging defects
FDA (Devices) · 2021-09-29