Z-2787-2026 Class II Ongoing
FDA device recall Z-2787-2026 was initiated by Medline Industries, LP on June 8, 2026 and is designated Class II. Reason for recall: 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 i… The recall status is ongoing. Affected quantity: 980 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- June 8, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 980 kits
Product Description
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
Code Information
DYKMBNDL116G UDI-DI 10198459156991 Lots 25GBG086 25JBF391 25KBA114 25KBN017 25LBQ601