Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS U
FDA device recall Z-2787-2026 · posted 2026-07-23 · Open, Classified
Recall details
- Recalling firm
- Medline Industries, LP
- 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.
- Action taken
- On June 8, 2026, the firm began notifying customers through First-Class Mail and email. Customers were instructed to over-label affected convenience kits with a label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- OKV
- Quantity affected
- 980 kits
- Distribution
- US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
- Date initiated
- 2026-06-08
- Date posted
- 2026-07-23
- Location
- Northfield, IL
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