MEDLINE INDUSTRIES, LP - Northfield product recalled over labeling errors

Recall date

July 23, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR…

Recall number

Z-2479-2025

FDA classification

Class II

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

Domestic distribution to FL and IL. No OUS distribution reported.

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)