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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE

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 Class 2 Device Recall MEDLINEsee related information
Date Initiated by FirmOctober 03, 2025
Date PostedNovember 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0510-2026
Recall Event ID 97815
Product Classification Eye tray - Product Code OJK
ProductMEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Code Information 1) REF: DYNJ37743D: UDI/DI 10193489600124 (each), 40193489600125 (case), Lot Number 25EMI333; 2) REF: DYNJ37743F: UDI/DI 10198459390685 (each), 40198459390686 (case), Lot Number 25GMD927.
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-359-1704
Manufacturer Reason
for Recall		Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
FDA Determined
Cause 2		Other
ActionMedline 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."
Quantity in Commerce1024 units
DistributionUS: MO
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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