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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-1883-2026
Recall Event ID 98601
Product Classification General surgery tray - Product Code LRO
ProductMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B CSTM ANGIO KIT - S VASC1109 CV PACK DYNJ46301C DR F PACK DYNJ41253B ENSEMBLE HEMORROIDES DYNJ56311A G TAVR PACK DYNJ61006 IR MINOR PACK DYNJ44139C MAJOR PLUS PACK DYNJ905160N MAXIMUM BARRIER BUNDLE PACK DYNJ35216C PCI PACK TBRHSC-LF DYNJ41941D PERC PACK-LF DYNJ0774759P PERIPHERAL ANGIOGRAPHY PK DYNJ42094B PROCEDURE PACK DYNJ55063B PTCA PACK DYNJ55359B ROBOTIC PACK DYNJ908706C SPECIAL PROCEDURES TRAY DYNJ41174A SYRINGE WIRE KIT SANFORD SAMPC0644 WPH EP PACK DYNJ62745 X-RAY PACK DYNJ44295G
Code Information DYNJ87052 UDI-DI 10198459005121 (EA) 40198459005122 (CS) LOTS 24FLA345 24FLA915 24HLB029 DYNJ83976 UDI-DI 10195327323196 (EA) 40195327323197 (CS) LOTS 24ABO128 DYNJ80700 UDI-DI 10195327066925 (EA) 40195327066926 (CS) LOTS 24BBD119 DYNJ42136B UDI-DI 10889942825288 (EA) 40889942825289 (CS) LOTS 23EMC679 24BMC063 24BMF939 24DMH398 24FMB963 24GMH870 24HMI957 24JMB273 24KMI914 VASC1109 UDI-DI 10889942779079 (EA) 40889942779070 (CS) LOTS 20EBW196 20FBR136 20HBV757 20JBC396 21ABE357 21ABT166 21BBN949 21CBS148 21EBB385 21KBD389 21LBD078 22BBV291 22DBN021 22EBO307 22GBZ351 22JBD956 23FBJ696 23HBR604 23IBF895 24JBK913 24KBR194 DYNJ46301C UDI-DI 10193489527889 (EA) 40193489527880 (CS) LOT 23LMH904 DYNJ41253B UDI-DI 10888277958173 (EA) 40888277958174 (CS) LOT 24ABP897 DYNJ56311A UDI-DI 10193489360127 (EA) 40193489360128 (CS) LOT 24ABR871 DYNJ61006 UDI-DI 10193489546194 (EA) 40193489546195 (CS) LOTS 21FBT962 21HBE414 21JBK356 21LBU392 22HBH070 22IBD976 22OBF481 23ABS489 23BBT198 23EBR237 23GBH211 23IBP468 23JBC690 23KBJ782 23LBT261 24BBQ276 24DBG218 24EBQ703 24GBE940 24IBD970 24JBA173 24KBQ943 DYNJ44139C UDI-DI 10193489226102 (EA) 40193489226103 (CS) LOTS 21EBS091 21GBI562 21HBR793 21IBX717 21KBJ549 22ABH554 22BBM456 22DBS762 22FBJ076 22FBR590 22IBB384 22KBF481 22LBB630 22OBG108 23ABJ826 23BBO865 23CBR417 23DBN752 23EBV786 23GBR439 23IBE449 23IBU640 23KBJ599 23LBP229 24ABC062 24EMG282 24IMC574 DYNJ905160N UDI-DI 10195327664473 (EA) 40195327664474 (CS) LOTS 24DMC432 24EMG685 DYNJ35216C UDI-DI 10889942952618 (EA) 40889942952619 (CS) LOTS 22GDA210 24IDA943 24KDA980 24LDA479 DYNJ41941D UDI-DI 10193489753707 (EA) 40193489753708 (CS) LOTS 20ABB748 20ABV122 20BBA524 20CBN068 20EBG674 20FBD191 20HBS587 20JBT996 21ABI859 21ABJ490 21BBD481 21CBH747 21DBH332 21JBE257 21JBU827 21LBR129 22CBZ848 22FBK880 22IBT430 22KBT522 22OBG445 23BBB312 23CBR316 23DBO494 23GBQ439 23HBM965 23HBX738 23IBU090 23JBV457 23LBF066 23LBT768 24CBG494 24DBG816 24EBC719 24JBF955 24KBD843 DYNJ0774759P UDI-DI 10195327246136 (EA) 40195327246137 (CS) LOT 24DMH153 DYNJ42094B UDI-DI 10889942820849 (EA) 40889942820840 (CS) LOTS 24CDA087 24EDA493 24HDA294 24IDA278 24IDB151 24IME505 24JMF227 24KMC897 24LME897 DYNJ55063B UDI-DI 10195327538972 (EA) 40195327538973 (CS) LOT 24ABP065 DYNJ55359B UDI-DI 10193489235517 (EA) 40193489235518 (CS) LOTS 23DBI651 23FBR555 23GBK876 23HBC455 23IBC298 23KBN808 24BBO002 24DBG256 24DBQ490 24EBJ876 24GBO458 DYNJ908706C UDI-DI 10195327664497 (EA) 40195327664498 (CS) LOT 24EMG687 DYNJ41174A UDI-DI 10195327366254 (EA) 40195327366255 (CS) LOT 23JBK389 SAMPC0644 UDI-DI 10193489356885 (EA) 40193489356886 (CS) LOT 20FDA159 DYNJ62745 UDI-DI 10193489688160 (EA) 40193489688161 (CS) LOT 24ABQ796 DYNJ44295G UDI-DI 10195327431273 (EA) 40195327431274 (CS) LOT 24IBH033
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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