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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 27, 2025
Date PostedDecember 05, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0886-2026
Recall Event ID 97968
Product Classification Cardiovascular procedure kit - Product Code OEZ
ProductMEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
Code Information UDI/DI 10193489621532 (each) 40193489621533 (case), Lot Number 25FMJ081
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer Reason
for Recall		Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline Industries issued an URGENT MEDICAL DEVICE RECALL to its consignee on 10/27/2025 via email. The notice explained the issue, potential risk, and requested the affected product be quarantined. Once the firm receives the response form, Medline will provide over-labels which are to be placed on kits that contain the recalled component and will state the affected component shall be removed and discarded from further use. Distributors and those further distributing the affected product are directed to notify those to whom the product was transferred or distributed of the recall. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce15 units
DistributionUS Nationwide distribution in the state of CA.
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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