Medline Sterile Basic Eye Pack 16: 1) Ref: Dynj37743d recallZ-0510-2026 · Medline Industries, LP · initiated Oct 3, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
FDA root cause category: Other
What the company is doing
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]."
Recall details
- Recall number
- Z-0510-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 3, 2025
- Posted by the FDA
- Nov 14, 2025
- Recalling firm
- Medline Industries, LP
- Quantity
- 1024 units
- Product code
- OJK
- Distribution
- US: MO
Product description
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Code information (models, lots, serial numbers)
1) REF: DYNJ37743D: UDI/DI 10193489600124 (each), 40193489600125 (case), Lot Number 25EMI333; 2) REF: DYNJ37743F: UDI/DI 10198459390685 (each), 40198459390686 (case), Lot Number 25GMD927.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ37743DMedline Industries, Inc. · Eye tray1 recall0 reports
- MEDLINE INDUSTRIES, INC. DYNJ37743FMedline Industries, Inc. · Eye tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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