Class II — MEDLINE INDUSTRIES, LP - Northfield
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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). |
| 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) |
| Quantity | 4 ea |
| Distribution | Domestic distribution to FL and IL. No OUS distribution reported. |
| Initiated | 2025-07-23 |
| Classified | 2025-08-28 |
| Recall number | Z-2479-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MEDLINE INDUSTRIES, LP - Northfield (Z-2479-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97388/
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