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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE CONVENIENCE KITS

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 Class 2 Device Recall MEDLINE CONVENIENCE KITSsee related information
Date Initiated by FirmFebruary 27, 2026
Date PostedApril 17, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1886-2026
Recall Event ID 98601
Product Classification Eye tray - Product Code OJK
ProductMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
Code Information DYNJ35056A UDI-DI 10889942227563 (EA) 40889942227564 (CS) LOT 24ABN639 DYNJ69318A UDI-DI 10195327370756 (EA) 40195327370757 (CS) LOTS 23DMD456 23EMB847 23HMB969 23IMC364 23JME011 23JMI841 23LMC384 24BMD333 24CMB768 24CMJ586 24EMJ527 24GMD970 24JMB408 24JMI594 24KMC774
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-633-5463
Manufacturer Reason
for Recall		Unapproved design changes to the products outside of the 510(k) clearance.
FDA Determined
Cause 2		Component change control
ActionOn February 27, 2026, the firm began notifying customers via email and first-class mail. Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.
Quantity in Commerce270,311 total
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
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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