Recall Z-2479-2025 ยท FDE Laparoscopy Kit
MEDLINE INDUSTRIES, LP - Northfield
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)
| Date | Aug 28, 2025 (initiated Jul 23, 2025) |
| Status | Open, Classified |
| Reason | Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis). |
| Root cause | Error in labeling |
| Action | Firm notified customers via email and first-class mail of the action. Medline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No kits are to be returned. |
| Quantity | 4 ea |
| Distribution | Domestic distribution to FL and IL. No OUS distribution reported. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.