Use cautionMedical device recall · FDA · Published July 23, 2025
Medline Recalls Foley Tray Kits with Incorrect Labeling Risk
Medline recalls kits containing BD SureStep Foley trays with mislabeled product sheets. Using these may cause minor injury or medical issues like infection or allergic reactions.
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).
Take action
Contact the company
📍Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
“Medline Recalls Foley Tray Kits with Incorrect Labeling Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51756-medline-recalls-foley-tray-kits-with-incorrect-labeling-risk. Based on FDA recall #Z-2479-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2479-2025%22&limit=1).
The FDA announced on July 23, 2025, that Medline Industries LP is recalling Medline Kits containing BD SureStep Foley Tray Systems due to incorrect product information insert sheets. The agency said the error poses a risk of minor injury or severe reactions such as anaphylaxis if mislabeled trays are used.
How to tell if you have it
Brand: Medline
Company: MEDLINE INDUSTRIES, LP - Northfield
SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR (only units from this SKU distributed)
Kit Lot Numbers: 25DBH902, 25ELA892, 25DLB031, 25DDA909
Distribution: Domestic to FL and IL
The hazard
The kits contain BD SureStep Foley Tray Systems with incorrect product information insert sheets. The FDA said if a mislabeled tray is used, patient risk ranges from minor injury to injury requiring medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).
Context
GovInfoNow's records show MEDLINE INDUSTRIES, LP - Northfield has 119 other recalls on record since 2021-10-22. Other recent recalls of similar products include Medline medical kits with light failure in newborn resuscitation kits (2025-07-25) and Medline ReNewal Reprocessed St. Jude Catheters that may contain particulates (2025-07-14). Additional recent recalls of similar products include a Medline Surgery Tray recall for tourniquet cuff detachment risk (2025-07-08), Medline Convenience Kits recalled for fungal contamination risk (2026-08-11), and Medline Convenience Kits recalled for contaminated components risk (2026-07-10).
How to tell if you have this one
Check for Medline kits with SKU CDS984076J that include BD SureStep Foley trays labeled as DYNJG001004A LAVH MINOR. These were distributed between specific lot numbers.
Brand
Medline
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Labels
Look for the SKU CDS984076J with BD SureStep Foley trays labeled DYNJG001004A LAVH MINOR.
Where it went and when
Where it was distributed
Distributed in Florida and Illinois.
Listed by the agency
Not listed
FDA distribution: “Domestic distribution to FL and IL. No OUS distribution reported.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Illinois.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2479-2025 (July 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2479-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.