Class II U.S. Food and Drug Administration

Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside

Recall published 4 months ago

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

The hazard: Mislabelling or misbranding

This is a packaging mix-up rather than a safety failure in the food itself — the wrong label, lid or sleeve went onto the product.

What the notice says: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

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-2592-2026
Published
July 1, 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
113, 843 kits
Distribution
Nationwide
Made in
United States
Lot / code info
DYNJ47665D UDI-DI 10193489952827 Lots 21HBJ571 21JBD819 21LBA976 22BBP310 22CBW541 22CMH003 22DMD476 22EMA241 22FMF056 22HMC694 22HME818 22IMC158 22IMG796 22JMD311 22LMD944 22NBC196 23AMB219 DYNJ30565D UDI-DI 10193489905205 Lots 21FDB653 21GDB275 DYNJ0854485V UDI-DI 10195327096885 Lots 22CMB440 22EMF763 22HMA699 22HMG186 22IMD134 22LME930 23BMC883 23CMB807 23CMI020 DYNJ28082D UDI-DI 10193489268676 Lots 21ABN806 21BBP110 21DBL217 21EBS784 21FBU514 DYNJ28082F UDI-DI 10193489949452 Lots 21HBM290 21IBQ174 21KBO096 21KBO098 DYNJ67349 UDI-DI 10193489895728 Lots 23JMA721 24BMF147 DYNJ57874C UDI-DI 10193489976618 Lot 24ABM611 DYNJSCL100 UDI-DI 10884389625583 Lot 24ABM801 DYNJSCL300 UDI-DI 10884389625606 Lot 24ABM802 DYNJ50779F UDI-DI 10193489436068 Lots 21DME914 21EMF097 21GMB502 21JMA420 22BMA533 22BMB246 22DMA002 22DMD984 22DMI243 22EMG746 22GMB725 22HMH063 22IME310 22KMA626 23AME217 23BME137 23DMH595 23EMI849 23FMJ773 23JMB530 23LMH087 24BMF696 24CMJ355 24DMA986 DYNJ41088B UDI-DI 10889942632794 Lot 21ABG127 DYNJ48085 UDI-DI 10888277546035 Lot 24AMF987 DYNJ37389N UDI-DI 10193489306019 Lots 21ABN379 21CBU277 21DBP810 DYNJ37389O UDI-DI 10193489925302 Lots 21FBL377 21GBD005 21HBN337 21JBW141 21JBW142 21LBG627 22ABH544 22CBF313 22DBD511 22DBE512 22FBS027 DYNJ62595A UDI-DI 10193489364262 Lots 21ABH085 21ABI181 21ABV975 21BBO277 21CBU091 21EBA810 DYNJ69997 UDI-DI 10195327004743 Lots 22DBK793 22IBD718 22IBE297 22OBC253 DYNJ47645B UDI-DI 10193489952834 Lots 21GBM457 21IBV915 21KBF627 21LBA512 21LME436 22DMI445 22EMD836 22FMC418 22GME258 22KMD663 DYNJ67918A UDI-DI 10195327042776 Lots 21LBP804 22CBZ026 22CBZ027 22OBG779 DYNJ56666C UDI-DI 10193489876079 Lots 21GMD986 21IMF632 21KMI417 22BMG174 22EMC819 22GMA609 22HMB858 22IME607 22JMI267 22LMA954 22LMH272 23BMH725 DYNJ44100L UDI-DI 10193489808810 Lots 20LMF752 21AMD830 21BMB938 21DMB287 21FMA141 21GMF673 21HMF024 21JMH879 21LMD528 22AME658 22CMD992 22DME753 22EMI131 22FMD999 22GMA910 22HMG804 22KMC260 22LMF595 DYNJ43664 UDI-DI 10888277065475 Lot 22FBP452 DYNJ0516014AF UDI-DI 10193489346978 Lots 21ABD076 21FBH595 21HBP277 21IBX390 21KBK660 22BBF662 22CBA986 22CBQ787 22DBI149 22FMC751 22FMF379 22IMA038 22IMH722 DYNJ907758A UDI-DI 10193489978384 Lot 21KBQ655 DYNJ62376A UDI-DI 10193489933598 Lot 24ABP679
UPC codes
10193489952827, 10193489905205, 10195327096885, 10193489268676, 10193489949452, 10193489895728, 10193489976618, 10884389625583, 10884389625606, 10193489436068, 10889942632794, 10888277546035, 10193489306019, 10193489925302, 10193489364262, 10195327004743, 10193489952834, 10195327042776, 10193489876079, 10193489808810

Products covered by this recall

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIAC CATH PACK DYNJ57874C CATH I PLUS-LF DYNJSCL100 CATH III PLUS-LF DYNJSCL300 CATH LAB ANGIOGRAPHY PACK DYNJ50779F CATH LAB PACK DYNJ41088B DYNJ48085 CATH LAB TRAY DYNJ37389N DYNJ37389O CATH PACK DYNJ62595A DYNJ69997 EP DRAPE PACK-LF DYNJ47645B HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918A INTERVENTIONAL PACK DYNJ56666C INTERVENTIONAL RAD PACK DYNJ44100L INTERVENTIONAL RADIOLOGY PACK DYNJ43664 INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AF OR HYBRID-MRMC DYNJ907758A VMA TRAY DYNJ62376A

Check your product

The notice names 22 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.

  • 10193489952827
  • 10193489905205
  • 10195327096885
  • 10193489268676
  • 10193489949452
  • 10193489895728
  • 10193489976618
  • 10884389625583
  • 10884389625606
  • 10193489436068
  • 10889942632794
  • 10888277546035
  • 10193489306019
  • 10193489925302
  • 10193489364262
  • 10195327004743
  • 10193489952834
  • 10195327042776
  • 10193489876079
  • 10193489808810

Lot or batch code

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

  • 843 kits

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 — This is a packaging mix-up rather than a safety failure in the food itself — the wrong label, lid or sleeve went onto the product.

  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.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

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?

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10193489952827, 10193489905205, 10195327096885; lot code 843 kits. 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?

Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.

Where was the recalled product sold?

It was distributed nationwide.

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