Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J Recalled by MEDLINE INDUSTRIES, LP - Northfield Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact MEDLINE INDUSTRIES, LP - Northfield directly.
Affected Products
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
Why Was This 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).
Where Was This Sold?
This product was distributed to 2 states: FL, IL
About MEDLINE INDUSTRIES, LP - Northfield
MEDLINE INDUSTRIES, LP - Northfield has 822 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report