—#215484

Product

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)

FDA product code: FDE — Laparoscopy Kit
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Medline Kit SKU Description UDI (EA) UDI (Case) Kit Lot Number CDS984076J GYN ROBOTIC 10198459283147 40198459283148 25DBH902 DYNJG001004A LAVH MINOR 10195327677329 40195327677320 25ELA892 DYNJG901001B CRANIOTOMY 10198459164316 40198459164317 25DLB031 DYNJ908819B KIT CRANIOTOMY 10198459102677 40198459102678 25DDA909

Why it was recalled

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 (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Domestic distribution to FL and IL. No OUS distribution reported.

Timeline

Recall initiated: 2025-07-23
Posted by FDA: 2025-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215484. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.