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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-2586-2026
Recall Event ID 99062
Product Classification Neurological tray - Product Code OJG
ProductConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK-LF DYNJ0854485S DEEP BRAIN STIMULATION PACK DYNJ0842793G NEURO ACCESSORY PACK DYNJ55385A NEURO ANGIO PACK DYNJ51697B DYNJ56509G DYNJ56509I DYNJ68063 DYNJ68845 DYNJ68845A DYNJ68845B NEURO CERVICAL PACK DYNJ0101287I DYNJ0101287L NEURO PACK DYNJ82103 DYNJ82103A NEURO TRAY DYNJ67075 DYNJ67075A DYNJ67075B NEURO VASCULAR PACK DYNJ62960B NEURO VP SHUNT PACK-LF DYNJ0843121J DYNJ0843121K NEUROLOGICAL CATH PACK DYNJ63434A DYNJ63434C NEURORADIOLOGY PK DYNJ40420D RADIOLOGY ANGIO MAJOR PACK-LF DYNJ62858A RADIOLOGY NEURO DRAPE PAC DYNJ61449 RRMC ANGIO PACK DYNJ36338B
Code Information DYNJ0854485S UDI-DI 10193489250558 Lot 21BMA604 DYNJ0842793G UDI-DI 10195327293666 Lots 22LDA183 23EDB049 23HDC042 23JDA988 24DDA005 DYNJ55385A UDI-DI 10193489762129 Lot 21ALA184 DYNJ51697B UDI-DI 10889942893652 Lots 21ABE325 21CBH476 21DBV407 21HBH690 21JBN408 21LBL194 21VBB105 22DBL109 22EBH117 22FBS410 22JBM660 22LBJ592 22NBG350 23BBR238 23CBH111 23DBN366 23GBE252 23HBP266 DYNJ56509G UDI-DI 10193489832082 Lots 21BBQ398 21BBR321 21CBO123 21DBM014 DYNJ56509I UDI-DI 10193489947113 Lots 21HBI572 21HBK163 DYNJ68063 UDI-DI 10193489872040 Lot 21FBN698 DYNJ68845 UDI-DI 10193489481006 Lot 21JBZ479 DYNJ68845A UDI-DI 10195327058104 Lot 22CBF908 22EBS916 DYNJ68845B UDI-DI 10195327211806 Lot 22HBL865 DYNJ0101287I UDI-DI 10193489434033 Lots 21CDA247 21EDA767 21GDC130 21HDA996 21KDA985 21LDA070 22BDA782 22CDC182 22EDB032 22GDA474 22IDB680 22KDB540 DYNJ0101287L UDI-DI 10195327567064 Lots 23LDB486 24BDB244 24FDA276 24FDB664 24HDC055 DYNJ82103 UDI-DI 10195327170998 Lots 22EMI175 22GMA639 DYNJ82103A UDI-DI 10195327260910 Lot 22KMH267 DYNJ67075 UDI-DI 10193489388473 Lot 21LLA292 DYNJ67075A UDI-DI 10195327054533 Lots 22CLB355 22DLA398 22ELA122 22ELA567 22FLA224 22HLA108 22HLB180 22ILB148 22KLA076 22LLA785 23ALA638 DYNJ67075B UDI-DI 10195327470852 Lots 23JLA177 23JLB271 23LLA274 24ALA492 24HLA695 24ILA933 24KLA029 24LLA559 25ALA880 DYNJ62960B UDI-DI 10193489911558 Lot 21HBD207 DYNJ0843121J UDI-DI 10193489444605 Lots 21ADB535 21CDC104 21FDC074 21HDB833 21HDC829 21LDA977 22ADB259 22BDB407 22EDB544 22GDA480 22HDB045 22KDA482 DYNJ0843121K UDI-DI 10195327286491 Lots 22KDB422 23DDB255 23EDB879 23GDA826 23IDC125 23JDA989 24ADC199 24BDB803 24GDB414 DYNJ63434A UDI-DI 10193489234886 Lots 21CBL981 21DBI016 21GBC948 21GBP926 21IBN513 21KBE479 21LBB983 22ABX228 22BBA201 22FBD018 22FBO659 22FBT491 22GBA743 22HBC353 22JBH927 22OBK976 DYNJ63434C UDI-DI 10195327445072 Lots 23GBQ452 23KBU655 DYNJ40420D UDI-DI 10193489925258 Lots 22BLB191 22DLA630 23ALA110 DYNJ62858A UDI-DI 10193489777550 Lot 21BMD592 DYNJ61449 UDI-DI 10193489567342 Lots 22LMD608 23EMG292 DYNJ36338B UDI-DI 10193489294071 Lots 21BMA293 21CMB071 21DMD790
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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