Medline Kits containing BD SureStep Foley Tray Systems:… — Class II medical device recall Z-2479-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-09-03, distributed in FL, IL. Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert shee
| Recall number | Z-2479-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2025-07-23 |
| Classified | 2025-08-28 |
| Reported by FDA | 2025-09-03 |
| Distributed | FL, IL |
| Quantity | 4 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10195327677329, 10198459102677, 10198459164316, 10198459283147, 40195327677320, 40198459102678, 40198459164317, 40198459283148 |
| Lot numbers | CDS984076JGYN |
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 for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2479-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.