Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
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: The product is a medical device with a potential for harm from excess raw material, and the FDA has classified this as a Class II recall.
Plain-English summary
Medline Industries, LP is recalling 980 Medline convenience kits that contain Bard Silastic Foley Catheters (French sizes 16, 18, 20) with 5cc balloons. The affected kits include lot numbers 25IMF461 and 25LMG907.
The manufacturer initiated the recall because an increased amount of raw material was found on the surface of the catheters. This issue may cause the catheters to exhibit staining on the surface, and the excess raw material may be harmful to users.
These kits were distributed nationwide in the United States, specifically in California, Florida, Maryland, Pennsylvania, and Texas.
The recalled product
- Product
- Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. SM-LAPAROSCOPIC PROSTATE PAC DYNJ61206J
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 980
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 (1)
- DYNJ61206J UDI-DI 10198459488597 Lots 25IMF461 25LMG907
Distribution
Part of a larger recall action
This product is one of 9 recalled by Medline Industries, LP 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 9 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Blood Culture Kits Recalled Due to Potential Seal Defects
FDA (Devices) · 2026-09-09
- SevereMedline Eye and Cataract Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled Due to Potential Packaging Seal Defects
FDA (Devices) · 2026-09-09
Same hazard · material contamination
See all →- High
- HighMedline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material
FDA (Devices) · 2026-07-29