| Date Initiated by Firm | February 27, 2026 |
| Date Posted | April 17, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1877-2026 |
| Recall Event ID |
98601 |
| Product Classification |
Cardiac catheterization kit - Product Code OES
|
| Product | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
ADULT CATH PACK-LF
DYNJ38395G
ANGIO DRAPE PACK (ADLUG)642-LF
DYNJ47665F
DYNJ47665G
ANGIO KIT PACK
DYNJ83746
DYNJ83746A
ANGIO PACK
DYNJ30565G
DYNJ51239C
DYNJ66631A
DYNJ69200A
DYNJ88276
ANGIO PHC
DYNJ37485D
ANGIO TRAY 116118
DYNJ37724K
ANGIO TRAY NO LIDO
DYNJ85557
DYNJ85557B
ANGIOGRAM-30852
DYNJVB91148A
ANGIOGRAPHY DRAPE PACK-LF
DYNJ0373221P
ANGIOGRAPHY PACK
DYNJ17218R
DYNJ44293F
DYNJ44293G
DYNJ44293J
DYNJ83516
ANGIOGRAPHY PACK-LF
DYNJ0854485X
ARTERIOGRAM
DYNJ28082I
BASIC HEART CATH PACK
DYNJVB1075B
CARDIAC CATH
DYNJ910293
CARDIAC CATH PACK
DYNJ68653B
DYNJ68653C
CARDIAC CATH PACK-LF
DYNJ85258
CATH LAB (EP) PACK
DYNJ65162B
CATH LAB ANGIO PACK-LF
DYNJ0545064AA
CATH LAB ANGIO TRAY
DYNJ83506A
CATH LAB PACK
DYNJ66366D
DYNJ66366F
DYNJT2202U
CATH LAB PROCEDURE PK
DYNJ57723C
CATH LAB TRAY
DYNJ37389P
DYNJ37389Q
CATH PACK
DYNJ62595C
DYNJ62595D
DYNJ69997A
HEART CATH PACK
DYNJ85783
HEART CATH-SFMC
DYNJ82434
INTERVENTIONAL PACK
DYNJ56666D
INTERVENTIONAL PACK-LF
DYNJ37211J
INTERVENTIONAL RADIOLOGY PK-LF
DYNJ0516014AI
IR PACK
DYNJ36752B
JUDKINS PACK
DYNJ51126C
M&E ANGIOGRAPHY PK
DYNJ83812
NEURO ANGIO PACK
DYNJ51697C
NEUROLOGICAL CATH PACK
DYNJ63434D
OR HYBRID-MRMC
DYNJ907758C
PTCA PACK
DYNJ55359C
DYNJ55359D
RADIOLOGY ANGIO MAJOR PACK
DYNJ62858C
SURGERY ANGIO PACK-LF
PHS677784013B
ANGIO ARTERIOGRAM PACK-LF DYNJ0774026J
ANGIO IR PACK DYNJ31196G
ANGIO PACK DYNJ30565F, DYNJ69200
ANGIOGRAM PACK-LF DYNJ21574K, DYNJ21574L
ANGIOGRAPHY PACK DYNJ26855G, DYNJ26855I
BGMC CARDIAC CATH PACK-LF DYNJ0664960D
CARDIAC CATH DYNJ59898B
CARDIAC CATH PACK DYNJ68653A, DYNJ69150A
CATH LAB ANGIO PACK-LF DYNJ0545064Y
CATH LAB PACK DYNJ28428F, DYNJ80457
CATH LAB-LF DYNJ51423F
CATH PACK DYNJ62595B, DYNJ62983A
CATH PROCEDURAL TRAY DYNJ43580D
GENERAL ANGIO PACK DYNJ57760C
HEART CATH PACK DYNJ69318
HEART CATH TRAY DYNJ53251J, DYNJ81557
IR PACK DYNJ65312
MAIN OR CATH LAB DYNJ61373A
M CARDIAC CATH DYNJ58339A
N CATH PACK NG140A
OR RADIOLOGY PACK DYNJ62747
RADIOLOGY PACK DYNJ42633C
R ANGIO PACK DYNJ36338C
SPECIAL TRAY DYNJ65756A
TAVR PACK DYNJ69246 |
| Code Information |
DYNJ0373221P
UDI-DI 10195327506575 (EA) 40195327506576 (CS)
LOTS 24ABR861
DYNJ0516014AI
UDI-DI 10198459246234 (EA) 40198459246235 (CS)
LOTS 25BME135
25EMI244
DYNJ0545064AA
UDI-DI 10195327327385 (EA) 40195327327386 (CS)
LOTS 23CMD735
24BMA467
24CME416
24DMG231
24EMI752
24FMD170
24HMD253
24JMC552
24LMA043
25AMJ675
25CMB252
25EMD050
25EMF726
DYNJ0854485X
UDI-DI 10195327450366 (EA) 40195327450367 (CS)
LOTS 23GMA609
23HMF271
23IMH767
23JMI189
23LMH350
24DMC322
24FMB078
24HMA888
24HMJ182
24LMB120
DYNJ17218R
UDI-DI 10195327459642 (EA) 40195327459643 (CS)
LOTS 23GDA609
23HDB136
23IDB699
23KDA473
DYNJ28082I
UDI-DI 10195327429713 (EA) 40195327429714 (CS)
LOTS 23HBC876
23KBE157
24BBC678
24DBN465
24FBQ528
24GBO066
24HBF409
24KBG843
DYNJ30565G
UDI-DI 10195327140687 (EA) 40195327140688 (CS)
LOTS 22DDB753
22FDB429
22HDB442
22KDA279
22LDB909
23BDB812
23EDA339
23GDA440
23IDA647
23IDB341
23KDB268
24BDA252
24CDB812
24EDC035
24HDC110
24IMA915
24JMI363
24KMG704
24LMF893
DYNJ36752B
UDI-DI 10195327226022 (EA) 40195327226023 (CS)
LOT 23IMD713
DYNJ37211J
UDI-DI 10195327363673 (EA) 40195327363674 (CS)
LOTS 24ABL975
24BBM554
24DBA215
24EBF356
24FBR841
24HBF463
24IBV426
24KBC581
24LBM346
DYNJ37389P
UDI-DI 10195327201418 (EA) 40195327201419 (CS)
LOTS 23DBO927
23FBC559
23GBF169
23GBJ160
23IBM982
DYNJ37389Q
UDI-DI 10195327531270 (EA) 40195327531271 (CS)
LOTS 23KBL184
23LMC983
23LMG114
24AME115
24BMJ169
24CMB351
24CMI800
24FMH298
24GMH700
24HMH956
24IMI993
24KMF785
24LMF430
DYNJ37485D
UDI-DI 10195327397333 (EA) 40195327397334 (CS)
LOTS 23DBP804
23FBH420
23GBF219
23HBJ487
23IBO358
23KBA337
23LBC194
24ABI270
24CMD265
24CMG190
24EMJ851
24GMK004
24HMF977
24JMC975
24KMH243
24LMG715
DYNJ37724K
UDI-DI 10195327531256 (EA) 40195327531257 (CS)
LOTS 23JBS842
23LMF451
24BMH462
24EMI397
24EMJ503
24GMK100
24HMH553
24JMA589
24KMJ234
DYNJ38395G
UDI-DI 10195327286767 (EA) 40195327286768 (CS)
LOTS 22LMF926
23BMA411
23DMD076
23DMG120
DYNJ44293F
UDI-DI 10195327265182 (EA) 40195327265183 (CS)
LOTS 23CBH106
DYNJ44293G
UDI-DI 10195327427276 (EA) 40195327427277 (CS)
LOTS 23HBI186
23HBX788
23IBP108
23JBQ388
23JBT471
23KBX452
23LBU382
24ABH531
24ABU590
24CBQ251
24FBS495
24HBB684
DYNJ44293J
UDI-DI 10198459252471 (EA) 40198459252472 (CS)
LOTS 25ABS436
25CBC411
25DBS739
25EBN111
25GBK945
DYNJ47665F
UDI-DI 10195327355210 (EA) 40195327355211 (CS)
LOTS 23GMI750
23IMG679
DYNJ47665G
UDI-DI 10195327535810 (EA) 40195327535811 (CS)
LOTS 23KMC220
23LMD957
24AMH318
24CMC513
24CMF048
24EMF765
24FMB398
24GMD088
24HMG619
24KMC285
DYNJ51126C
UDI-DI 10195327299996 (EA) 40195327299997 (CS)
LOTS 24EBL991
24GBL127
24HBB815
24IBI837
24KBT622
DYNJ51239C
UDI-DI 10195327663728 (EA) 40195327663729 (CS)
LOTS 24FBM878
DYNJ51697C
UDI-DI 10195327517267 (EA) 40195327517268 (CS)
LOTS 24HBJ453
24JBQ619
24KBL433
DYNJ55359C
UDI-DI 10198459167447 (EA) 40198459167448 (CS)
LOTS 24JBW626
24LBJ492
25ABM557
DYNJ55359D
UDI-DI 10198459253584 (EA) 40198459253585 (CS)
LOTS 25CBJ836
25EBB180
25FBC620
DYNJ56666D
UDI-DI 10195327366780 (EA) 40195327366781 (CS)
LOTS 23FMB079
23HMC084
23JMH176
DYNJ57723C
UDI-DI 10195327533007 (EA) 40195327533008 (CS)
LOT 24GMA688
DYNJ62595C
UDI-DI 10195327386511 (EA) 40195327386512 (CS)
LOTS 23FBD527
23FBK131
DYNJ62595D
UDI-DI 10195327482626 (EA) 40195327482627 (CS)
LOTS 23IBD384
23JBT585
23KBV027
23LBS746
24ABX161
24BBA663
24DBO214
24EBN761
24GBJ844
24IBT077
24JBX775
24KBR861
DYNJ62858C
UDI-DI 10195327265212 (EA) 40195327265213 (CS)
LOTS 23GMB070
24BMD149
24HMA369
24HMJ618
24JME908
DYNJ63434D
UDI-DI 10195327611200 (EA) 40195327611201 (CS)
LOTS 24BBU728
24CBK568
24FBE982
24GBP703
24HBS440
24JBD723
24JBN341
24LBQ810
DYNJ65162B
UDI-DI 10195327443948 (EA) 40195327443949 (CS)
LOTS 23KBA866
23LBL832
DYNJ66366D
UDI-DI 10195327493387 (EA) 40195327493388 (CS)
LOTS 23LMC414
24BMD428
24EMG916
24EMJ523
24GMC227
24GMG298
24GMI398
DYNJ66366F
UDI-DI 10198459033117 (EA) 40198459033118 (CS)
LOTS 24HMI310
24IMB847
24IMD381
DYNJ66631A
UDI-DI 10195327225193 (EA) 40195327225194 (CS)
LOTS 23ABB849
23ABP692
23BBP518
23HBN017
23IBO135
24BBU796
24EBA783
24GBD375
24HBG027
24IBG782
24JBU401
24KBH848
24LBE218
DYNJ68653B
UDI-DI 10195327475970 (EA) 40195327475971 (CS)
LOTS 23IBO333
23JBE362
23KBS420
DYNJ68653C
UDI-DI 10195327626570 (EA) 40195327626571 (CS)
LOTS 24BBU897
24EBB962
24EBJ449
24FBR693
24HBB850
DYNJ69200A
UDI-DI 10195327489410 (EA) 40195327489411 (CS)
LOTS 23IMC515
24AMD850
24DMH188
24FMF806
24JMF887
24JMJ455
DYNJ69997A UDI-DI 10195327260385 (EA) 40195327260386 (CS)
LOTS 23KBU803
23LBM407
24ABP852
24BBV440
24DBE698
24EBF945
24FBD806
24FBO409
24HBD424
24IBA964
24JBH315
24KBF590
DYNJ82434
UDI-DI 10195327195991 (EA) 40195327195992 (CS)
LOTS 23EBW505
23HBD267
23KBT910
DYNJ83506A
UDI-DI 10195327366186 (EA) 40195327366187 (CS)
LOTS 23FBD320
23GBC962
23HBI399
23JBR658
23LBG496
24ABV721
24CBC537
24CBU407
24EBC887
24FBC272
24GBS961
24HBQ313
24JBA160
24JBW202
DYNJ83516
UDI-DI 10195327277017 (EA) 40195327277018 (CS)
LOTS 23FBR130
24EBL005
24FBG676
24GBO653
DYNJ83746
UDI-DI 10195327300692 (EA) 40195327300693 (CS)
LOTS 23FBJ158
DYNJ83746A
UDI-DI 10195327450199 (EA) 40195327450190 (CS)
LOTS 23LBO128
24DBN523
24EBC851
24FBC179
DYNJ83812
UDI-DI 10195327310097 (EA) 40195327310098 (CS)
LOTS 23GBU635
23HBC113
23JBX909
DYNJ85258
UDI-DI 10195327485696 (EA) 40195327485697 (CS)
LOT 24CBQ941
DYNJ85557
UDI-DI 10195327516802 (EA) 40195327516803 (CS)
LOT 23LBV118
DYNJ85557B
UDI-DI 10198459140099 (EA) 40198459140090 (CS)
LOT 24LBL658
DYNJ85783
UDI-DI 10195327548858 (EA) 40195327548859 (CS)
LOT 24BBB824
DYNJ88276
UDI-DI 10198459139963 (EA) 40198459139964 (CS)
LOT 24JBP183
DYNJ907758C
UDI-DI 10195327193836 (EA) 40195327193837 (CS)
LOT 23CBJ259
DYNJ910293
UDI-DI 10195327618711 (EA) 40195327618712 (CS)
LOT 24CBB990
24DBP431
24GBO286
24GBP221
24HBL812
24KBG045
24KBN510
24LBR413
25CBJ733
25DBD091
25DBM647
DYNJT2202U
UDI-DI 10195327263010 (EA) 40195327263011 (CS)
LOTS 23HME786
DYNJVB1075B
UDI-DI 10195327254735 (EA) 40195327254736 (CS)
LOTS 23JLA749
DYNJVB91148A
UDI-DI 10198459182372 (EA) 40198459182373 (CS)
LOTS 25DLA750
25ELB006
25GLA721
PHS677784013B
UDI-DI 10195327498887 (EA) 40195327498888 (CS)
LOTS 24HMG073
24IMA820
24IME550
24KMB118
DYNJ0774026J
UDI-DI 10193489271645 (EA) 40193489271646 (CS)
LOTS 23BME179
23CMH777
23EMG669
23FMD595
23HMB354
23IMH606
23JMA027
24ABV703
DYNJ31196G
UDI-DI 10198459095610 (EA) 40198459095611 (CS)
LOTS 24HBW974
24JBJ110
DYNJ30565F
UDI-DI 10195327031961 (EA) 40195327031962 (CS)
LOTS 21JDC595
21LDA804
22CDA234
DYNJ69200
UDI-DI 10193489906813 (EA) 40193489906814 (CS)
LOTS 23DMF486
23EMF929
23FMF496
23GMB826
23GMI809
DYNJ21574K
UDI-DI 10195327008970 (EA) 40195327008971 (CS)
LOTS 23FLA441
23GLB169
23ILA271
23JLA395
23JLA665
23KLB042
23LLA789
24BLA140
24BLB079
24DLA079
24FLA280
DYNJ21574L
UDI-DI 10198459094385 (EA) 40198459094386 (CS)
LOTS 24HLA450
24HLA848
24ILA065
24JLA291
24KLA039
24KLA924
24LLA313
DYNJ26855G
UDI-DI 10195327008956 (EA) 40195327008957 (CS)
LOTS 22ABE569
22ABZ784
22BBD499
22EBM551
22FBP986
22JBT802
22OBH709
23BBT658
23EBR341
23KBC736
23LBP243
24BBH599
24BBU885
24DBH273
24EBA834
24FBD738
24GBF739
24GBW918
DYNJ26855I
UDI-DI 10198459094392 (EA) 40198459094393 (CS)
LOTS 24IBR372
24JBS600
24KBO719
DYNJ0664960D
UDI-DI 10193489397031 (EA) 40193489397032 (CS)
LOTS 24GBE748
24GBV256
24IBO585
24JBC423
24JBG501
24KBK205
DYNJ59898B
UDI-DI 10195327037130 (EA) 40195327037131 (CS)
LOT 23JBN221
DYNJ68653A
UDI-DI 10195327095703 (EA) 40195327095704 (CS)
LOTS 23BBS119
23EBK331
23FBG953
23GBQ487
DYNJ69150A
UDI-DI 10195327046330 (EA) 40195327046331 (CS)
LOT 24BBB818
DYNJ0545064Y
UDI-DI 10193489469042 (EA) 40193489469043 (CS)
LOTS 21CBO976
21DBA926
21FBO930
21HBC707
21HBQ780
21KBG377
21LBB707
21LBM663
22BBT446
22CBE190
22DMH122
22EMF009
22FMH972
22GMB541
22IME216
22KMD333
22LMG693
DYNJ28428F
UDI-DI 10889942218448 (EA) 40889942218449 (CS)
LOTS 23EBV379
23GBM428
23HBG542
23JBH720
23JBR648
24BBI852
24CBC564
24CBK578
24DBS782
24GBJ992
24HBR901
24JBO787
DYNJ80457
UDI-DI 10195327039417 (EA) 40195327039418 (CS)
LOT 24ABT460
DYNJ51423F
UDI-DI 10193489456813 (EA) 40193489456814 (CS)
LOTS 23ELA935
23FLB069
23GLA872
23GLA983
23HLB130
23JLA430
23JLA961
23LLA538
DYNJ62595B
UDI-DI 10193489930443 (EA) 40193489930444 (CS)
LOT 23CBK312
DYNJ62983A
UDI-DI 10193489324792 (EA) 40193489324793 (CS)
LOTS 23CMD917
23IME947
DYNJ43580D
UDI-DI 10193489922622 (EA) 40193489922623 (CS)
LOTS 23EDB907
23FDB773
23IDB785
23JDA831
23LDA819
24ADB496
24CDA214
24EDB119
24FDB521
24GDB467
24IDA596
24JDA196
24JDB828
24JDC323
DYNJ57760C
UDI-DI 10195327079390 (EA) 40195327079391 (CS)
LOTS 23FMI541
23GMC743
23IMC143
23IMD071
23JMG748
24BMD271
24CMF285
24FMD857
24HMG516
24IMB711
24JMH057
DYNJ69318
UDI-DI 10193489930344 (EA) 40193489930345 (CS)
LOT 23BME178
DYNJ53251J
UDI-DI 10193489965469 (EA) 40193489965460 (CS)
LOTS 23BBB184
23BBJ802
23CBF225
23KBH360
24ABB431
24BBQ972
24CBN146
24DBR758
24GBP113
24HBS157
24IBG551
24IBH388
24KBM359
DYNJ81557
UDI-DI 10195327122621 (EA) 40195327122622 (CS)
LOT 24DBN954
DYNJ65312
UDI-DI 10193489266405 (EA) 40193489266406 (CS)
LOT 24ABP045
DYNJ61373A
UDI-DI 10195327014698 (EA) 40195327014699 (CS)
LOTS 23GBF047
23KBD741
23KBL501
23LBL092
DYNJ58339A
UDI-DI 10193489483147 (EA) 40193489483148 (CS)
LOT 24DBG343
NG140A
UDI-DI 10889942945474 (EA) 40889942945475 (CS)
LOT 23IBK929
DYNJ62747
UDI-DI 10193489687149 (EA) 40193489687140 (CS)
LOT 23JBI082
DYNJ42633C
UDI-DI 10193489810493 (EA) 40193489810494 (CS)
LOTS 23FMG920
23FMH918
DYNJ36338C
UDI-DI 10193489915532 (EA) 40193489915533 (CS)
LOTS 23DMH629
23FME052
23IME630
23JMI386
23KMB592
23LMI240
24AMI028
DYNJ65756A
UDI-DI 10193489423273 (EA) 40193489423274 (CS)
LOTS 23EBR170
23FBJ964
DYNJ69246
UDI-DI 10193489917970 (EA) 40193489917971 (CS)
LOTS 23BBM275
24CBQ263
24DBM916
24DBR138
24EBJ938
24IBH260
24JBF386
24JBT909
|
| 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.
|