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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 FirmFebruary 27, 2026
Date PostedJune 25, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2594-2026
Recall Event ID 99062
Product Classification Central venous catheter tray - Product Code OFF
ProductConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ47899A INVASIVE LINE INSERTION DYNJ44123B NON VASCULAR PACK DYNJ68037A VASCULAR ACCESS PACK-LF DYNJ0101291F
Code Information DYNJ41089 UDI-DI 10884389891360 Lot 21BBB592 DYNJ62827A UDI-DI 10193489306606 Lot 24BBN289 DYNJ47899A UDI-DI 10889942574681 Lots 21GBI377 21IBL299 21LBE099 21LBU529 22JBV803 DYNJ44123B UDI-DI 10195327381653 Lots 23FBR833 23GBN041 23HBW014 23JBO264 23JBW218 23KBI873 DYNJ68037A UDI-DI 10195327003630 Lots 21JBQ304 21LBQ205 22ABN185 22DBT349 22EBL611 22HBH550 22IBN880 22JBH689 22KBS987 22OBA368 23ABD642 23BBH830 23DBL865 23EBT367 23FBM946 23GBT261 DYNJ0101291F UDI-DI 10195327286644 Lots 22KDB751 23EDA119 23EDB388 23FDA396 23GDA313 23HDA759 23LDB909 24ADB667 24GDA294 24HDB515
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		Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA Determined
Cause 2		No Marketing Application
ActionThis entry catalogues SKUs communicated through the same letter documented in RES 98601 which were inadvertently missed in the initial report to the FDA. Firm began notifying customers on February 27, 2026 via letters titled "URGENT MEDICAL DEVICE RECALL". Customers were instructed to immediately check stock for affected product and quarantine any affected units. Upon receipt of the customers' response form reporting the quantity of affected product on hand, the firm will provide over-labels to place on affected inventory. Labels contain instructions for staff to remove and discard the affected component prior to using the kit.
Quantity in Commerce113, 843 kits
DistributionUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of 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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