Class II U.S. Food and Drug Administration

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate recall: Unapproved design changes to the products outside of the 510(k) clearance

Recall published 6 months ago

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

The hazard: Mislabelling or misbranding

The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

What the notice says: Unapproved design changes to the products outside of the 510(k) clearance.

Why it matters: The product carries the wrong label, the wrong lid or the wrong packaging. The food inside is generally fine; the problem is that the package describes something else, which defeats anyone relying on it.

Symptoms and when to call a doctor

There is no illness associated with mislabelling itself. The exception is where the undeclared contents include an allergen, in which case treat it as an allergen recall and watch for the reaction that person normally has.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1876-2026
Published
April 29, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
270,311 total
Distribution
Nationwide
Made in
United States
Lot / code info
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 ***Updated 5/20/26 - The following lots were included in the customer notification but not in the FDA submission.*** DYNJ0220880V Lots 21DLA453 21FLA083 21ILA147 21KLA059 22ALA849 22DLA707 22FLA700 22HLA272 22ILA188 22ILA237 22ILA641 22JLA662 22KLA836 22KLA939 22LLA399 25KMB595 25LMA384; DYNJ30077D Lots 21ABB348 21ABR327 21DBQ397 21FBM873 21GBL539 21IBB390 21JBO220 21KBC302 21KBV079 21LBT528 22ABZ834 22DBD744 22EBG375 22JBK533 22KBO291 22OBM411 23ABD824 23ABO419 23DBB788 23EBS951 23HBB563 23IBG762 23JBT149 24CBR583; DYNJ32555C Lots 21DMA301 21DMD929 21EMB686 21FMA163 22KMD644 23AMB073 24LMH114 25BMA103 25BMD349; DYNJ46153B Lots 21CBL359 21FBE618 21GBF346 21HBQ716 21IBW154 21KBI853 21LBA401 22ABE877 22BBW978 22CBU323 22EBN725 22FBQ420 22GBJ229 22HBD581 22IBL258 22JBM061 22KBD440 22NBA199 23ABG769 23BBE724 25BBR850 25EBA187; DYNJ47710C Lots 21CBM120 21GBL622 21KBA849 21KBA925 22ABX239 22CBP654 22JBI023 22LBR933 23BBT611 25BBF414 25CBJ501; DYNJ61015B Lots 21AMB131 21BMB923 21BMC128 21CMD384 21DMD441 21FMD102 21GME205 21JMG652 22AMD050 22AME244 22DME869 22FMA872 22FMD246 22GMG534 22IMB779 22IMF574 22JMG963 23AMD815 23BMB886 23DMC707; DYNJ66631 Lots 21IBH359 21VBC892 22BBW852 22DBJ281 22EBJ532 22GBA380
UPC codes
10889942122820, 40889942122821, 10193489859485, 40193489859486, 10193489368321, 40193489368322, 10193489853643, 40193489853644, 10888277012042, 40888277012043, 10193489674910, 40193489674911, 10889942054688, 40889942054689, 10889942138630, 40889942138631, 10193489747621, 40193489747622, 10193489765519, 40193489765510

Products covered by this recall

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

Check your product

The notice names 25 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10889942122820
  • 40889942122821
  • 10193489859485
  • 40193489859486
  • 10193489368321
  • 40193489368322
  • 10193489853643
  • 40193489853644
  • 10888277012042
  • 40888277012043
  • 10193489674910
  • 40193489674911
  • 10889942054688
  • 40889942054689
  • 10889942138630
  • 40889942138631
  • 10193489747621
  • 40193489747622
  • 10193489765519
  • 40193489765510

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 20ADA585 DYNJ32555C UDI-DI 10193489859485
  • 24ABU775 DYNJ0220880V UDI-DI 10889942054688
  • 24BBD166 DYNJ61015B UDI-DI 10193489368888
  • 311 total

Package size

Match the net weight or the piece count on the front of the pack.

  • 10 mL

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Mislabelled

Medline Industries, LP — The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

  1. Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.
  2. Keep a photo of the mismatched label, which makes the refund conversation much shorter.
  3. Check the lot code on your pack — these mix-ups are usually confined to a short production window.
  4. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10889942122820, 40889942122821, 10193489859485; lot code 20ADA585 DYNJ32555C UDI-DI 10193489859485, 24ABU775 DYNJ0220880V UDI-DI 10889942054688, 24BBD166 DYNJ61015B UDI-DI 10193489368888. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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