Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medline

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmFebruary 27, 2026
Date PostedJune 25, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2593-2026
Recall Event ID 99062
Product Classification Cardiovascular procedure kit - Product Code OEZ
ProductConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO PACK-LF DYNJ0842873K HYBRID PACK DYNJ65925B DYNJ65925C NON VASCULAR PACK DYNJ68037 PACEMAKER DYNJ901681D PACEMAKER PACK DYNJ51853C DYNJ51853D DYNJ60606A PACER PACK DYNJ40952A RADIOLOGY VASCULAR ACCESS TRAY DYNJVB1303A SM- INTERVENTIONAL DRAPE PK-LF DYNJ0780143K VASCULAR ACCESS PACK-LF DYNJ0101291D VASCULAR DSC DYNJ69172 DYNJ69172B VASCULAR HYBRID DYNJ57543F DYNJ57543I DYNJ57543J VASCULAR PACK DYNJ61702A
Code Information DYNJ905291B UDI-DI 10193489950373 Lots 21GBO405 21JBX734 21LBO216 DYNJ905291C UDI-DI 10195327062545 Lots 22BBB434 22CBT553 22CBT556 22FBE950 22GBZ363 22LBQ583 23ABE635 23CBI463 DYNJ28082G UDI-DI 10195327050559 Lots 22BBL073 22DBT712 22FBU975 22IBD336 22LBH042 23BBG319 23CBW711 23EBF014 DYKM2130A UDI-DI 10195327630904 Lot 24ELA817 DYNJ0678934J UDI-DI 10195327637378 Lot 24FMI941 DYNJ23456J UDI-DI 10193489449839 Lot 21BMB927 DYNJ0842873K UDI-DI 10195327286613 Lots 22KDB463 23ADA210 23CDA339 23CDB773 23EDB190 23FDB457 23HDA476 23IDC327 23JDB182 23JDC057 24ADB081 24BDB286 24CDB934 24GDA042 24HDA590 24HDC238 DYNJ65925B UDI-DI 10193489925326 Lots 21FLA630 21GLA415 21HLA270 21JLA166 21KLA318 22CLA057 22CLA817 22DLA206 22ELA964 DYNJ65925C UDI-DI 10195327201371 Lots 23CLB075 23ELA853 23HLA442 23ILA022 DYNJ68037 UDI-DI 10193489473889 Lots 21ABT991 21HBL486 DYNJ901681D UDI-DI 10193489308099 Lot 24EMH538 DYNJ51853C UDI-DI 10193489269000 Lots 21CBB992 21DBA936 21FBE790 21HBN274 21KBA699 21KBP057 DYNJ51853D UDI-DI 10195327101336 Lots 22EBB104 22HBF054 22IBE507 22JBJ069 22KBS971 22LBT245 22NBG258 22OBI766 23ABI851 DYNJ60606A UDI-DI 10193489693386 Lot 24BBA469 DYNJ40952A UDI-DI 10193489941906 Lots 21GBR992 21JBX464 22BBS266 22CBP195 22EBS044 DYNJVB1303A UDI-DI 10193489928358 Lots 23ELB088 23FLA355 DYNJ0780143K UDI-DI 10195327477240 Lot 24AMI797 DYNJ0101291D UDI-DI 10193489381931 Lots 21CDC066 21EDB518 21GDC932 21HDC814 22BDA495 22DDB731 22DDC457 22EDB642 22GDA964 22JDA001 22JDC181 DYNJ69172 UDI-DI 10193489899603 Lots 21GMA692 21IMH791 DYNJ69172B UDI-DI 10195327487027 Lot 23KMC637 DYNJ57543F UDI-DI 10195327279028 Lot 23AMF931 DYNJ57543I UDI-DI 10195327359362 Lot 23CMD266 DYNJ57543J UDI-DI 10195327416027 Lots 23GMD945 23GMG266 DYNJ61702A UDI-DI 10193489470321 Lots 21CBN901 21FBM858 21GBE705
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.
-
-