Medline Kits containing BD SureStep Foley Tray Systems recallZ-2479-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Jul 23, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Error in labeling
What the company is doing
Firm notified customers via email and first-class mail of the action. Medline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.
Recall details
- Recall number
- Z-2479-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 23, 2025
- Posted by the FDA
- Aug 28, 2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 4 ea
- Product code
- FDE
- Distribution
- Domestic distribution to FL and IL. No OUS distribution reported.
Product description
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)
Code information (models, lots, serial numbers)
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
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ908819BMedline Industries, Inc. · Orthopedic tray2 recalls0 reports
- Medline Industries, Inc. DYNJG901001BMedline Industries, Inc. · Orthopedic tray2 recalls0 reports
- Medline Industries, Inc. DYNJG001004AMedline Industries, Inc. · laparoscopy kit1 recall0 reports
- Medline Industries, Inc. CDS984076JMedline Industries, Inc. · Gynecological laparoscopic kit1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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