Recall Z-2785-2026
Medline Industries, LP · initiated June 8, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F
Codes / lots: DYNJ63392F UDI-DI 10198459315572 Lots 25GLA905 25HLA240 25HLA894 25JLA091 25KLA775 25LLA985 26ALA670
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.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-2785-2026
- Initiated
- June 8, 2026
- Posted by FDA
- July 23, 2026
- Product code
- OHD – Gynecological Laparoscopic Kit
- Quantity
- 980 kits
- Distribution
- US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2779-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | 06/08/2026Open, Classified |
| Z-2780-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | 06/08/2026Open, Classified |
| Z-2781-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | 06/08/2026Open, Classified |
| Z-2782-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | 06/08/2026Open, Classified |
| Z-2783-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | 06/08/2026Open, Classified |
| Z-2784-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | 06/08/2026Open, Classified |
| Z-2786-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | 06/08/2026Open, Classified |
| Z-2787-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | 06/08/2026Open, Classified |