| Date Initiated by Firm | February 27, 2026 |
| Date Posted | April 17, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1876-2026 |
| Recall Event ID |
98601 |
| Product Classification |
Angiography/angioplasty kit - Product Code OEQ
|
| Product | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
JUDKINS PACK DYNJ51126
ANGIO PACK DYNJ32555C, DYNJ66631
ANGIO TRAY DYNJ46153B
ANGIOGRAPHY PACK DYNJ26855F
ANGIOGRAPHY PACK-M-LF DYNJ24530I
ANGIOGRAPHY TRAY-LF DYNJ0220880V, DYNJ30077D
CATH LAB ANGIO PACK-LF DYNJ0545064X
CATH LAB PACK DYNJ39057C
FEMORAL ANGIOGRAPY SET UP DYNJ61015B
RAD-ANGIO PACK DYNJ47710C
SURGERY ANGIO PACK-LF PHS677784013A |
| Code Information |
DYNJ51126
UDI-DI 10889942122820 (EA)
40889942122821 (CS)
LOT 20ADA585
DYNJ32555C
UDI-DI 10193489859485 (EA) 40193489859486 (CS)
LOTS 21HMF699
21IMF813
21JMA855
21KMD605
22DMB423
22FMD574
22HMB608
22LMA169
23BMA114
23EMB817
23EMG153
23KMB692
23KMH359
23LMH085
24AMC563
24CMD587
24DMD256
24DMG305
24FMD717
24IMI650
24JMC830
DYNJ66631
UDI-DI 10193489368321 (EA) 40193489368322 (CS)
LOTS 22BBB494
22BBB497
DYNJ46153B
UDI-DI 10193489853643 (EA) 40193489853644 (CS)
LOTS 23EBM225
23FBC884
23HBP278
23IBV999
23KBC319
23LBK125
24CBF100
24DBE952
24FBP262
24GBN960
24HBO921
24IBO007
24IBU941
24JBK669
24LBK644
DYNJ26855F
UDI-DI 10888277012042 (EA) 40888277012043 (CS)
LOTS 20CBI049
20EBB600
20FBK900
20GBD331
20GBL795
20IBC788
20JBM786
20KBF148
21BBK244
21EBR327
21HBB849
21IBQ809
21OBA396
DYNJ24530I
UDI- DI 10193489674910 (EA) 40193489674911 (CS)
LOT 24ABU775
DYNJ0220880V
UDI-DI 10889942054688 (EA) 40889942054689 (CS)
LOTS 23HLA505
23HLB257
23JLA021
23JLA059
23KLA121
23KLA231
23KLA582
23LLA817
24ELA405
24ELA796
24HLA596
25AMI609
25BMH660
25CMA797
25DMF893
DYNJ30077D
UDI-DI 10889942138630 (EA) 40889942138631 (CS)
LOTS 23FBQ479
23LBL707
24CBC495
24EBQ346
24GBK895
24HBD023
24HBP290
24JBJ112
DYNJ0545064X
UDI-DI 10193489747621 (EA) 40193489747622 (CS)
LOTS 20BBL115
20CBA649
20DBB933
20DBP595
20HBW939
20KBI815
21ABK039
21ABK542
DYNJ39057C
UDI-DI 10193489765519 (EA) 40193489765510 (CS)
LOT 24BBD166
DYNJ61015B
UDI-DI 10193489368888 (EA) 40193489368889 (CS)
LOTS 23CMG023
23FBN151
DYNJ47710C
UDI-DI 10889942214495 (EA) 40889942214496 (CS)
LOTS 23FBF109
23GBB677
23JBP270
23LBO688
24DBD356
24FBP326
24IBC340
24KBJ788
PHS677784013A
UDI-DI 10193489604337 (EA) 40193489604338 (CS)
LOTS 20BBR301
20IMA683
21BMC467
21CMC052
21FMD140
21IMF229
22AMA959
22AME458
23GMA491
23GMD585
|
| 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.
|