Recall Z-2785-2026 ยท OHD Gynecological Laparoscopic Kit
Medline Industries, LP
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F
| Date | Jul 23, 2026 (initiated Jun 8, 2026) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.