Changeflow GovPing Government General Medline Convenience Kits Syringe Recall, Class II
Urgent Enforcement Amended Final

Medline Convenience Kits Syringe Recall, Class II

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Summary

FDA issued a Class II recall for Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes. The recall was initiated by the firm on February 27, 2026, and posted on April 17, 2026. Affected products span over 60 product codes across cardiac catheterization, angiography, and interventional radiology kit categories, with lot codes distributed across manufacturing dates from 2022 through 2025.

Published by FDA on accessdata.fda.gov . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

FDA classified a Class II recall for Medline Industries' convenience kits containing 10mL polycarbonate colored syringes. The recall affects over 60 distinct product codes including cardiac cath packs, angio packs, PTCA packs, TAVR packs, and related trays and procedure kits. Affected lot codes span manufacturing dates from 2022 through 2025.

Healthcare facilities that use these catheterization and angiography kits should immediately verify their inventory against the affected SKU and lot code list. Facilities should quarantine any matching product and contact Medline for return instructions. Class II recalls involve temporary or reversible health consequences where use of the affected product may cause temporary or reversible health problems.

Archived snapshot

Apr 20, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Class 2 Device Recall MEDLINE CONVENIENCE KITS

- Databases

| |

| 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards |

| CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | |

| New Search | ) |

| | 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-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 | 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. | |

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FDA
Filed
April 17th, 2026
Instrument
Enforcement
Branch
Executive
Legal weight
Binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Product recall response Medical device distribution Catheterization kit distribution
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Topics
Product Safety Healthcare

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