FDA Device recall Z-2479-2025
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIO…
- FDA Device
- Class II
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIO… by Medline Industries Northfield, citing 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 inju….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2479-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-23 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | FL, IL |
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).
Identifiers
| code_info | Medline Kit SKU Description UDI (EA) UDI (Case) Kit Lot Number CDS984076J GYN ROBOTIC 10198459283147 40198459283148 25D…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Medline Industries Northfield
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All Medline Industries Northfield recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2479-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.