| Date Initiated by Firm | February 27, 2026 |
| Date Posted | April 17, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1884-2026 |
| Recall Event ID |
98601 |
| Product Classification |
Neurological tray - Product Code OJG
|
| Product | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
ANGIO KIT PACK DYNJ50783B
ANGIO PHC DYNJ37485C
C.I.C.N. ANGIO PACK DYNJ53064B
FHT P NEURO PACK DYNJ39931D
NEURO ARTERIOGRAM PACK-LF DYNJ0948060F
NEURO KIT NAM0003
NEURO PACK DYNJ61542D
NEURO RADIOLOGY PACK DYNJ59903B
NEURO TRAY DYNJ84872A
PK, CATH LAB-ANGIO DYNJ44027F
QVH IR NEURO PACK DYNJ62176 |
| Code Information |
DYNJ50783B
UDI-DI 10193489227376 (EA) 40193489227377 (CS)
LOT 23FBF183
DYNJ37485C
UDI-DI 10193489760002 (EA) 40193489760003 (CS)
LOTS 20BBX692
20DBC089
20EBG816
20FBR153
20HBN288
20IBK578
20KBW291
21BBB266
21CBW198
21FBH674
21GBS840
21GBS842
21JBU703
21LBX721
22BBV337
22EBN708
22IBJ467
22JBH996
22KBU901
22OBJ150
23ABG615
23BBF603
23CBC306
DYNJ53064B
UDI-DI 10193489789164 (EA) 40193489789165 (CS)
LOT 23HMI416
DYNJ39931D
UDI-DI 10193489459364 (EA) 40193489459365 (CS)
LOTS 23BBB182
23DBK363
24HBJ427
24JBI915
24JBV985
24KBH817
25GBI670
25IBS445
DYNJ0948060F
UDI-DI 10889942825103 (EA) 40889942825104 (CS)
LOTS 23FMA240
24EBR693
24GLB224
24HLA705
24JLA904
NAM0003
UDI-DI 10193489222555 (EA) 40193489222556 (CS)
LOTS 20DBO375
20GBC317
20GBJ719
20HBC159
20HBD815
20HBF519
20IBA514
23CMC981
23DMC490
23DMF161
23GMA353
23HME057
23HMG264
23IMF173
23JMF878
23JMH829
23KME885
23LMA780
23LMD088
23LMG059
24AMF167
24AMH128
24EMG747
24HMJ041
24JMC680
DYNJ61542D
UDI-DI 10195327507923 (EA) 40195327507924 (CS)
LOT 24FMC929
DYNJ59903B
UDI-DI 10195327131203 (EA) 40195327131204 (CS)
LOTS 23EBQ216
23HBC089
23IBE176
23KBL439
23LBO494
24ABL938
24CBQ708
24EBB108
24FBA584
24FBN897
24JBC983
24JBO349
24KBB061
24KBT242
24LBP491
DYNJ84872A
UDI-DI 10195327481506 (EA) 40195327481507 (CS)
LOTS 23LBN462
24ABC179
DYNJ44027F
UDI-DI 10193489783490 (EA) 40193489783491 (CS)
LOTS 21FLA184
21FLA910
21ILA783
21JLA542
21LLA177
22ALA731
22BLA802
22DLA497
22ELA818
22FLA432
22GLB161
22HLB062
22JBC795
22JBM045
22KBO209
22KBO210
23DBR512
23FBQ563
23GBK955
23HBY707
23JBT738
23KBF311
23KBU563
24ABW467
24GBK560
24HBB843
24IBI798
24IBR643
24JBF292
DYNJ62176
UDI-DI 10193489631784 (EA) 40193489631785 (CS)
LOTS 23ELA677
23GLA263
23KLB156
|
| 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 2 | 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.
|