FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M
- Recall number
- Z-2780-2026
- Recalling firm
- Medline Industries, LP
- Product
- Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M
- Status
- Open, Classified
- Initiated
- 2026-06-08
- Posted
- 2026-07-23
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 980 kits
- Distribution
- US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
- Lot, serial or model codes
- DYNJ68477L UDI-DI 10198459487866 Lots 25HMF458 25LME235 DYNJ68477M UDI-DI 10198459678738 Lots 26CMK219 26EMG622
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHD
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28