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

Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

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-1883-2026
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
DYNJ87052 UDI-DI 10198459005121 (EA) 40198459005122 (CS) LOTS 24FLA345 24FLA915 24HLB029 DYNJ83976 UDI-DI 10195327323196 (EA) 40195327323197 (CS) LOTS 24ABO128 DYNJ80700 UDI-DI 10195327066925 (EA) 40195327066926 (CS) LOTS 24BBD119 DYNJ42136B UDI-DI 10889942825288 (EA) 40889942825289 (CS) LOTS 23EMC679 24BMC063 24BMF939 24DMH398 24FMB963 24GMH870 24HMI957 24JMB273 24KMI914 VASC1109 UDI-DI 10889942779079 (EA) 40889942779070 (CS) LOTS 20EBW196 20FBR136 20HBV757 20JBC396 21ABE357 21ABT166 21BBN949 21CBS148 21EBB385 21KBD389 21LBD078 22BBV291 22DBN021 22EBO307 22GBZ351 22JBD956 23FBJ696 23HBR604 23IBF895 24JBK913 24KBR194 DYNJ46301C UDI-DI 10193489527889 (EA) 40193489527880 (CS) LOT 23LMH904 DYNJ41253B UDI-DI 10888277958173 (EA) 40888277958174 (CS) LOT 24ABP897 DYNJ56311A UDI-DI 10193489360127 (EA) 40193489360128 (CS) LOT 24ABR871 DYNJ61006 UDI-DI 10193489546194 (EA) 40193489546195 (CS) LOTS 21FBT962 21HBE414 21JBK356 21LBU392 22HBH070 22IBD976 22OBF481 23ABS489 23BBT198 23EBR237 23GBH211 23IBP468 23JBC690 23KBJ782 23LBT261 24BBQ276 24DBG218 24EBQ703 24GBE940 24IBD970 24JBA173 24KBQ943 DYNJ44139C UDI-DI 10193489226102 (EA) 40193489226103 (CS) LOTS 21EBS091 21GBI562 21HBR793 21IBX717 21KBJ549 22ABH554 22BBM456 22DBS762 22FBJ076 22FBR590 22IBB384 22KBF481 22LBB630 22OBG108 23ABJ826 23BBO865 23CBR417 23DBN752 23EBV786 23GBR439 23IBE449 23IBU640 23KBJ599 23LBP229 24ABC062 24EMG282 24IMC574 DYNJ905160N UDI-DI 10195327664473 (EA) 40195327664474 (CS) LOTS 24DMC432 24EMG685 DYNJ35216C UDI-DI 10889942952618 (EA) 40889942952619 (CS) LOTS 22GDA210 24IDA943 24KDA980 24LDA479 DYNJ41941D UDI-DI 10193489753707 (EA) 40193489753708 (CS) LOTS 20ABB748 20ABV122 20BBA524 20CBN068 20EBG674 20FBD191 20HBS587 20JBT996 21ABI859 21ABJ490 21BBD481 21CBH747 21DBH332 21JBE257 21JBU827 21LBR129 22CBZ848 22FBK880 22IBT430 22KBT522 22OBG445 23BBB312 23CBR316 23DBO494 23GBQ439 23HBM965 23HBX738 23IBU090 23JBV457 23LBF066 23LBT768 24CBG494 24DBG816 24EBC719 24JBF955 24KBD843 DYNJ0774759P UDI-DI 10195327246136 (EA) 40195327246137 (CS) LOT 24DMH153 DYNJ42094B UDI-DI 10889942820849 (EA) 40889942820840 (CS) LOTS 24CDA087 24EDA493 24HDA294 24IDA278 24IDB151 24IME505 24JMF227 24KMC897 24LME897 DYNJ55063B UDI-DI 10195327538972 (EA) 40195327538973 (CS) LOT 24ABP065 DYNJ55359B UDI-DI 10193489235517 (EA) 40193489235518 (CS) LOTS 23DBI651 23FBR555 23GBK876 23HBC455 23IBC298 23KBN808 24BBO002 24DBG256 24DBQ490 24EBJ876 24GBO458 DYNJ908706C UDI-DI 10195327664497 (EA) 40195327664498 (CS) LOT 24EMG687 DYNJ41174A UDI-DI 10195327366254 (EA) 40195327366255 (CS) LOT 23JBK389 SAMPC0644 UDI-DI 10193489356885 (EA) 40193489356886 (CS) LOT 20FDA159 DYNJ62745 UDI-DI 10193489688160 (EA) 40193489688161 (CS) LOT 24ABQ796 DYNJ44295G UDI-DI 10195327431273 (EA) 40195327431274 (CS) LOT 24IBH033 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ35216C lots 21BDA005 21CDA164 21DDB532 21IDA938 21KDB822 22ADB494 22ADC166 22CDB658 22DDC504 22HDA355 22LDA336 23BDB027 23BDC034 23DDA002 23DDA917 23GDA443 23HDA139 23JDC163 23LDA319 24DDA760 24GDA206 24GDB408 25BDA073 25DDA617 25DDB847; DYNJ41941D lots 24LBU189 25EBO278; DYNJ42094B lots 21DDA142 21EDA157 21FDA721 21HDC553 21JDB308 21KDC411 22ADB304 22DDA696 22EDB388 22GDB457 22HDC130 22KDB833 23ADA446 23BDB104 23DDA367 23EDA799 23FDB379 23HDB674 23KDA291 23KDC457 24ADA586 25DMB689 25EMH157; DYNJ42136B lots 20XBH732 21FBD068 21FBP137 21GBM895 21IBO938 21JBW334 21LBK626 22DBB070 22DBT749 22DBT751 22GBL802 22KMB909 23AMA925 23AMA926 23DMC128 23EMK206 23FMD274 23GMI199 23IMF729 23KMG485 25DMG003 25EMJ002; DYNJ44139C lots 21ABF720 21BBP639 21OBA387 DYNJ46301C 23EMD296; DYNJ55359B lots 21CBY049 21HBJ347 21KBK603 21LBU329 22BBN805 22DBG945 22DBG946 22EBI619 22EBI620 22GBV248 22IBD917 22JBP712 22KBO285 22LBF294 23BBN404 23CBU106; DYNJ61006 lots 21BBM590 21DBE579 25EBA174; DYNJ62745 lots 21CBZ899 21EBI827 21HBB755 21KBR329 21LBP817 22BBB761 22BBY454 22FBG531 22FBG532 22GBH888 22HBH100 22JBS334 23ABF660…
UPC codes
10198459005121, 40198459005122, 10195327323196, 40195327323197, 10195327066925, 40195327066926, 10889942825288, 40889942825289, 10889942779079, 40889942779070, 10193489527889, 40193489527880, 10888277958173, 40888277958174, 10193489360127, 40193489360128, 10193489546194, 40193489546195, 10193489226102, 40193489226103

Products covered by this recall

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B CSTM ANGIO KIT - S VASC1109 CV PACK DYNJ46301C DR F PACK DYNJ41253B ENSEMBLE HEMORROIDES DYNJ56311A G TAVR PACK DYNJ61006 IR MINOR PACK DYNJ44139C MAJOR PLUS PACK DYNJ905160N MAXIMUM BARRIER BUNDLE PACK DYNJ35216C PCI PACK TBRHSC-LF DYNJ41941D PERC PACK-LF DYNJ0774759P PERIPHERAL ANGIOGRAPHY PK DYNJ42094B PROCEDURE PACK DYNJ55063B PTCA PACK DYNJ55359B ROBOTIC PACK DYNJ908706C SPECIAL PROCEDURES TRAY DYNJ41174A SYRINGE WIRE KIT SANFORD SAMPC0644 WPH EP PACK DYNJ62745 X-RAY PACK DYNJ44295G

Check your product

The notice names 35 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.

  • 10198459005121
  • 40198459005122
  • 10195327323196
  • 40195327323197
  • 10195327066925
  • 40195327066926
  • 10889942825288
  • 40889942825289
  • 10889942779079
  • 40889942779070
  • 10193489527889
  • 40193489527880
  • 10888277958173
  • 40888277958174
  • 10193489360127
  • 40193489360128
  • 10193489546194
  • 40193489546195
  • 10193489226102
  • 40193489226103

Lot or batch code

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

  • 24ABO128 DYNJ80700 UDI-DI 10195327066925
  • 24BBD119 DYNJ42136B UDI-DI 10889942825288
  • 23LMH904 DYNJ41253B UDI-DI 10888277958173
  • 24ABP897 DYNJ56311A UDI-DI 10193489360127
  • 24ABR871 DYNJ61006 UDI-DI 10193489546194
  • 24DMH153 DYNJ42094B UDI-DI 10889942820849
  • 24ABP065 DYNJ55359B UDI-DI 10193489235517
  • 24EMG687 DYNJ41174A UDI-DI 10195327366254
  • 23JBK389 SAMPC0644 UDI-DI 10193489356885
  • 20FDA159 DYNJ62745 UDI-DI 10193489688160
  • 24ABQ796 DYNJ44295G UDI-DI 10195327431273
  • 24IBH033
  • 24LBU189 25EBO278
  • 21BBM590 21DBE579 25EBA174

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 — Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

  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. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.
  3. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.
  4. Keep a photo of the mismatched label, which makes the refund conversation much shorter.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

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 10198459005121, 40198459005122, 10195327323196; lot code 24ABO128 DYNJ80700 UDI-DI 10195327066925, 24BBD119 DYNJ42136B UDI-DI 10889942825288, 23LMH904 DYNJ41253B UDI-DI 10888277958173. 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?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Where was the recalled product sold?

It was distributed nationwide.

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