MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.

FDA device recall Z-0510-2026 · posted 2025-11-14 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

Reason for recall

Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.

Action taken

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 recalls@medline.com."

Root cause

Other

Status

Open, Classified

Product code

OJK

Quantity affected

1024 units

Distribution

US: MO

Date initiated

2025-10-03

Date posted

2025-11-14

Location

Northfield, IL