FDA Medical devices recall ·
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters… recall
- Recall number
- Z-2779-2026
- Date
- (initiated June 8, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 980 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I
Why was it recalled?
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710
Distribution
US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
States: California Florida Maryland Pennsylvania Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2779-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.