Z-2260-2026Class II

Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P

Name: Z-2260-2026 Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
Creator: Medline Industries, LP
Published: 2026-04-10
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-04-10 / Open, Classified / root cause: labeling and UDI

FDA source

Medline Industries, LP began a recall of Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P on 2026-04-10. FDA classified it as Class II and gives the reason as "Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2260-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-10
Posted: 2026-05-28
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
Product code: OJK Eye Tray
Reason for recall: Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code 1180100777), but the syringes inside are U-100 insulin syringes.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to it consignees on 4/10/2026 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed on the enclosed response form. Quarantine all affected product. 2. Please complete and return the enclosed response form listing the quantity of affected product you have in inventory. Even if you do not have any affected product in inventory, please complete and return the response form. 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 8 kits
Distribution: US Nationwide distribution in the states of California.
Product codes and lots: UDI/DI 10198459151569 (each), 40198459151560 (case), Lot Numbers: 26BMC538

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2260-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2260-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28

Product code OJK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)