Class II FDA device recall · Z-1878-2026

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT PACK-LF DYNJ0842516G CATHETER PACK DYNJ61926 EP DRAPE PACK-LF DYNJ47645C EP PACK DYNJ47782G EPS ACCESSORY PACK DYNJT2201S H CLINIC VASCULAR PK DYNJ33415A HEART FAILURE PACK DYNJ64877B HYBRID PACK DYNJ65925D INTERVENTIONAL RAD PACK DYNJ44100M INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AG MV-PACEMAKER PACK-LF DYNJ41556F NEURO RADIOLOGY RICHMOND DYNJ68365D OR HYBRID-M DYNJ907758D, DYNJ907758F PACEMAKER DYNJ907960C PACEMAKER PACK DYNJ42557B DYNJ61411 DYNJ61411A DYNJ61411B DYNJ80160 PACER PACK DYNJ40952B PERIPHERAL ARTERIOGRAM RAD DYNJ61383B RADIOLOGY PACK DYNJ54762D TAVR PACK DYNJ55338B DYNJ69246A VASCULAR ACCESS TRAY DYNJ52606F VASCULAR TRAY DYNJ49802C VEIN PACK DYNJ57512 DYNJ58063 DYNJ84953

Why it was recalled

Unapproved design changes to the products outside of the 510(k) clearance.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

DYNJ69246B UDI-DI  10198459335266 (EA) 40198459335267 (CS) LOT 25EBM356  DYNJ905291D  UDI-DI 10195327393090 (EA) 40195327393091 (CS) LOTS 24JBO127    24LBJ199     DYNJ86769  UDI-DI 10195327674168 (EA) 40195327674169 (CS) LOT  24EMF716     DYNJ26783D UDI-DI 10193489616750 (EA) 40193489616751 (CS) LOTS 23DBJ248    23EBK921    23FBS130    23HBB516    23IBS065    23JBP123    23LBP196    24ABR004    24ABR121    24BBG855    24GBV377    24JBI914    24KBD153    24LBB665     DYNJ35615G  UDI-DI 10195327099404 (EA) 40195327099405 (CS) LOT  23EBR748     DYNJ0842516G  UDI-DI 10195327286392 (EA) 40195327286393 (CS) LOTS  24CDB991    24GDB891    24IDA796    24KDB683     DYNJ61926  UDI-DI 10193489610406 (EA) 40193489610407 (CS) LOTS  23CBK311    23DBM226    23FBP893    23GBN159    23HBC859    23JBH552    23LBV456    24DBM081    24EBS504    24FBR479     DYNJ47645C  UDI-DI 10195327355173 (EA) 40195327355174 (CS) LOTS  23IMH312    23LMD467    24BMB620    24DMD512    24FMF757    24GMD538    24JMC369    24KMB831    24LMD945     DYNJ47782G  UDI-DI 10195327495640 (EA) 40195327495641 (CS) LOT  24GMA622     DYNJT2201S  UDI-DI 10195327263003 (EA) 40195327263004 (CS) LOT  23HMG629     DYNJ33415A  UDI-DI 10888277792555 (EA) 40888277792556 (CS) LOT  24CBG963     DYNJ64877B  UDI-DI 10193489415896 (EA) 40193489415897 (CS) LOTS  23CBF259    23HBM117    23HBO973    23KBD360    23LBG859    24ABB266    24CMJ034    24FMD963    24HMH185    24JMD105     DYNJ65925D  UDI-DI 10195327531188 (EA) 40195327531189 (CS) LOT  24DLA029     DYNJ44100M  UDI-DI 10195327324988 (EA) 40195327324989 (CS) LOTS  23IMG347    23JMI669    23LME170    24AMI085    24CMA877    24CMJ446    24DME309    24FMC387    24FMC900    24FMF012    24FMH007    24GMC363    24HMF632    24JMF664    24LMD487     DYNJ0516014AG  UDI-DI 10195327271640 (EA) 40195327271641 (CS) LOTS  23BME190    23DMH005    23KMH805    23KMI253    23LMH275    24AMH347    24CMI868    24DMI402    24DMK427    24EMG633    24IMB650    24IMJ127    24KMC298     DYNJ41556F  UDI-DI 10193489968170 (EA) 40193489968171 (CS) LOTS  23IME423    23IMH983     DYNJ68365D  UDI-DI 10195327525040 (EA) 40195327525041 (CS) LOT  23JBH517     DYNJ907758D  UDI-DI 10195327351335 (EA) 40195327351336 (CS) LOTS        23FBP055    23HBC362    23HBL227    23HBX060    23KBB106    24CBT278    24CBV291    24HBE808    24HBR182     DYNJ907758F  UDI-DI 10198459128622 (EA) 40198459128623 (CS) LOTS  24JBM379    24KBC281     DYNJ907960C  UDI-DI 10195327347451 (EA) 40195327347452 (CS) LOT  24CBT833     DYNJ42557B  UDI-DI 10889942135806 (EA) 40889942135807 (CS) LOT 24BBA461     DYNJ61411  UDI-DI 10193489562705 (EA) 40193489562706 (CS) LOT  23GBH973     DYNJ61411A  UDI-DI 10195327483234 (EA) 40195327483235 (CS) LOTS  23IBH456    23JBN809     DYNJ61411B  UDI-DI 10195327628697 (EA) 40195327628698 (CS) LOTS  24DBE155    24LBE209     DYNJ80160  UDI-DI 10195327013226 (EA) 40195327013227 (CS) LOT  24CBJ103     DYNJ40952B  UDI-DI 10195327203726 (EA) 40195327203727 (CS) LOTS  24EBT279    24GBQ711    24HBR555    24JBO326    24LBM313     DYNJ61383B  UDI-DI 10193489751277 (EA) 40193489751278 (CS) LOTS  23FLA104    23HLA490    23ILB095    23KBP994    23LBD911    24ALA301     DYNJ54762D  UDI-DI 10195327031725 (EA) 40195327031726 (CS) LOT  24ABX637     DYNJ55338B  UDI-DI 10193489859027 (EA) 40193489859028 (CS) LOT  22GMG972     DYNJ69246A  UDI-DI 10198459178931 (EA) 40198459178932 (CS) LOTS  24LBA791    25ABA813    25CBF356    25DBA846     DYNJ52606F  UDI-DI 10193489343298 (EA) 40193489343299 (CS) LOTS  23ELB102    23GLA496    23HLB190    23JLA642    23JLB201    24BLA295    24DLA690    24FLA227    24GLA493    24HLA557    24ILA766    24KLA315     DYNJ49802C  UDI-DI 10193489461602 (EA) 40193489461603 (CS) LOT  24BBD110     DYNJ57512  UDI-DI 10889942748273 (EA) 40889942748274 (CS) LOT  24ABS819     DYNJ58063 10889942816675 40889942816676 24ABM343     DYNJ84953 10195327440299 40195327440290 24FBM720  ***Updated 5/20/26 - The following lots were included in the customer notification but not the FDA submission.***   DYNJ0516014AG Lots 22LMD393 23DMG745 23HMB539 23LMH275A;  DYNJ0842516G Lots 22KDA699 22LDC077 23DDB550 23GDA061 23HDC455 23JDA626 23LDB990 25BMH951 25BMI475;  DYNJ26783D Lots 21CBL983 21FBE677 21GBR689 21JBA358 21KBF796 21LBG769 22ABX397 22CBA514 22FBK918 22GBO115 22JBU884 22KBJ430 23ABN303 23BBN053 25ABH287 25ABV765 25BBE142 25CBE875;  DYNJ40952B Lots 22HBH043 22JBJ979 23DBR448 23FBE598 23JBL097 23KBH476 24ABR924 25BBS344  DYNJ44100M Lots 23AMJ315 23CMH807 23EMG216 23EMG763 23GMH722 23HMF163 23LMC066 25BMB884 25CMC633 25EMG169;  DYNJ47645C Lots 23CMB852 23DMB824 23FMB662 25AMC532;  DYNJ52606F Lots 21AKA467 21DKA121 21GLA734 21HLA612 21ILA348 21JLA304 21LLA164 22ALA074 22ALA885 22BLA931 22DLA955 22FLA562 22HLA294 22ILB142 22JLA807 23BLA662 23CLA943 25ALA106 25CLA447;  DYNJ61383B Lots 21CLA367 21FLA054 21GLA195 21JLA060 21LLA062 22CLA063 22CLA337 22DLA685 22DLB071 22ELB118 22JLA236 22KLA964 23ALA936 23CLA512 23ELA390 23FLA461 23GLA377 23JLB155 23KLA301 23KLA891 23LLA228;  DYNJ61411 Lots 21LBN952 22LBD611 23EBB430;  DYNJ61411B Lots 25ABI638;  DYNJ61926 Lots 21GBD658 21GBL566 21HBD840 21LBC437 22BBW042 22DBC423 22DBD732 22FBA218 22FBE801 22IBJ796 22JBC580 22KBO429 23CBV820;  DYNJ64877B Lots 21FBQ067 21HBI622 21JBJ094 21KBJ217 21KBY182 22BBX515 22DBS770 22FBJ150 22GBG601 22HBG389 22IBH792 22KBF545 22LBB678 23ABI442 23ABT369 23BBM722 23CBU312;  DYNJ65925D Lots 23KLA302 24FLA113 24HLA304 24KLA472 25BLA348 25DLA829;  DYNJ80160 Lots 24ABN644;  DYNJ905291D Lots 23EBV965 23FBN523 23IBC601 23KBP627 24ABC741 24BBK009 24DBI116 24DBI720 24FBE328 24GBT122;  DYNJ907758D Lots 23CBO746

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.

Recall record

Recalling firm: Medline Industries, LP
Product type: Devices
Recall number: Z-1878-2026
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2026-02-27

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1878-2026 · Source: openFDA enforcement.