Medline procedure kits, labeled as: OL OCULAR, REF… recallZ-1713-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Mar 19, 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 - Northfield 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
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
FDA root cause category: Under Investigation by firm
What the company is doing
Medline Industries issued an IMMEDIATE ACTION REQUIRED recall notice to its consignees on 03/19/2025 via email and US mail. The notice explained the issue, potential risk and requested all affected product be destroyed. Credit will be issued upon receipt of completed destruction form. Those who have transferred or further distributed the product were directed to notify those to whom the product was transferred or distributed. For questions contact 866-359-1704 or email [email protected].
Recall details
- Recall number
- Z-1713-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 19, 2025
- Posted by the FDA
- May 1, 2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 30 units
- Product code
- OJK
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
Product description
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
Code information (models, lots, serial numbers)
UDI/DI 10195327385521 (EA)40195327385522 (CS), Lot Numbers: 23LME299
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ906183KMedline Industries, Inc. · Eye tray2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96630).
- Z-1707-2025 · Open, ClassifiedMedline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
- Z-1708-2025 · Open, ClassifiedMedline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
- Z-1709-2025 · Open, ClassifiedMedline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEK…
- Z-1710-2025 · Open, ClassifiedMedline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
- Z-1711-2025 · Open, ClassifiedMedline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
- Z-1714-2025 · Open, ClassifiedMedline procedure kits, labeled as: HAND, REF DYNJ902002J
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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