Recall archive / FDA device enforcement
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MIN... — FDA record Z-2479-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 23, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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)
- 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).
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 4 ea
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2479-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to FL and IL. No OUS distribution reported.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 3, 2025
- Recall initiation date
- Jul 23, 2025
- Center classification date
- Aug 28, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.