MEDLINE INDUSTRIES, LP - Northfield: Device Recall
Recall #Z-2479-2025 · 07/23/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2479-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Status
- Ongoing
- Date Initiated
- 07/23/2025
- Location
- Northfield, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 ea
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).
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)
Distribution Pattern
Domestic distribution to FL and IL. No OUS distribution reported.
Other Recalls by MEDLINE INDUSTRIES, LP - Northfield
- Class I: Dangerous 07/25/2025
- Class I: Dangerous 07/25/2025
- Class I: Dangerous 07/14/2025
- Class II: Risk 07/08/2025
- Class II: Risk 07/07/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.