Medline Convenience Kits Class II Syringe Recall - Unapproved Design Changes

Class 2 Device Recall MEDLINE CONVENIENCE KITS

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| | Class 2 Device Recall MEDLINE CONVENIENCE KITS | |

Date Initiated by Firm	February 27, 2026
Date Posted	April 17, 2026
Recall Status	Open , Classified
Recall Number	Z-1883-2026
Recall Event ID	98601
Product Classification	General surgery tray - Product Code LRO
Product	Medline 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 Contact | Haley Barclay
800-633-5463 |
| Manufacturer Reason
for Recall | Unapproved design changes to the products outside of the 510(k) clearance. |
| FDA Determined
Cause | Component change control |
| Action | On 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 Commerce | 270,311 total |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados. |
| Total Product Life Cycle | TPLC 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. | |