- 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.
- Affected products (lot / model / serial)
- CDS980523M UDI-DI 10195327508913 Lots 25KBJ177 25LBO527 26ABT761
- Units affected
- 980 kits
- Distribution pattern
- US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2784-2026
- Recall initiated
- June 8, 2026
- FDA classification date
- July 23, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 99301
- Last updated on HTM Vibe
- August 4, 2026