Z-0510-2026Class II

Medline Sterile Basic Eye Pack 16: 1) Ref: Dynj37743d; 2) Ref: Dynj37743f

Name: Z-0510-2026 Medline Sterile Basic Eye Pack 16: 1) Ref: Dynj37743d; 2) Ref: Dynj37743f
Creator: Medline Industries, LP
Published: 2025-10-03
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-10-03 / Open, Classified / root cause: packaging

FDA source

Medline Industries, LP began a recall of MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F on 2025-10-03. FDA classified it as Class II and gives the reason as "Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0510-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-03
Posted: 2025-11-14
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Sterile Basic Eye Pack 16: 1) Ref: Dynj37743d; 2) Ref: Dynj37743f.
Product code: OJK Eye Tray
Reason for recall: Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
Root cause tag: packaging
FDA root cause: Other
Action: Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignee on 10/03/2025 via USPS first class mail and email. The notice explained the issue with the product, potential risk to the patient, and requested the following actions: "1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product.2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.Website link: https://recalls.medline.comRecall Reference #: R-25-202-FGRecall Code: 3.Your account will receive credit once the response form is submitted.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 request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]."
Quantity in commerce: 1024 units
Distribution: US: MO
Product codes and lots: 1) REF: DYNJ37743D: UDI/DI 10193489600124 (each), 40193489600125 (case), Lot Number 25EMI333; 2) REF: DYNJ37743F: UDI/DI 10198459390685 (each), 40198459390686 (case), Lot Number 25GMD927.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0510-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0510-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-14

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)