FDAFDA · Food and drugs·Recall number Z-2479-2025
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)
Published September 3, 2025 · Recall initiated: July 23, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Domestic distribution to FL and IL. No OUS distribution reported.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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