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-2585-2026
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
DYNJ905651B UDI-DI 10193489925067 Lot 24BME750 00-402001S UDI-DI 10889942893645 Lots 21ABV063 21BBK296 21OBA437 DYNJ0842516F UDI-DI 10193489352375 Lots 21BDB242 21CDC063 21HDB970 21IDB395 21KDC355 22BDA157 22DDB628 22FDA331 22GDB353 PHS463660F UDI-DI 10195327096991 Lots 22BBT652 22DBK236 DYNJ43580C UDI-DI 10889942249398 Lots 21BDB710 21DDB799 DYNDA2213A UDI-DI 10889942925421 Lots 23LBC294 DYNJ65277A UDI-DI 10193489409536 Lots 24BBD609 24BBD609A DYNJ0842793F UDI-DI 10193489345230 Lots 21CDA191 21CDC092 21EDA769 21GDB289 21HDC822 22BDB295 22DDA792 22EDB725 22IDC164 DYNJ67918 UDI-DI 10193489459081 Lots 21ABP630 21DBL459 21EBD905 21HBE280 21HBE285 21IBS959 21VBD188 DYNJ56666B UDI-DI 10888277740273 Lots 21BMB700 21CMA789 DYNJ44123A UDI-DI 10889942952977 Lots 21ABV982 21CBB916 21HBQ740 21KBE936 21VBC816 22ABS461 22CBX354 22DBD608 22EBT322 22GBR526 22HBS119 22LBA937 22LBM278 23ABJ758 23BBG292 23CBD680 DYNJ51126B UDI-DI 10195327044138 Lots 22ADA961 22BDC241 22DDA320 22DDB652 22FBD047 22FBH293 22HBQ223 22HBY535 22JBG518 PAIN1454 UDI-DI 10193489688863 Lots 21CBA985 21DBU969 21FBN495 21GBG636 21KBJ919 22ABJ583 22BBN243 22IBT753 22KBA570 23ABK226 23IBE552 23JBF419 23KBJ152 DYNJ905160I UDI-DI 10193489397482 Lots 21BBE987 21DBD058 21EBC916 DYNJ0843063J UDI-DI 10193489345377 Lots 21CDA233 21EDC220 21GDC682 21IDA570 21JDA064 21LDA151 22ADC136 22CDB166 22EDA616 22FDB836 22HDB150 22KDA481 DYNJ37304F UDI-DI 10889942727919 Lot 23KMI510 DYNJ56386B UDI-DI 10888277762886 Lots 21CBX170 21GBQ837 21JBW253 21LBH797 22ABX259 22BBC246 22CBW026 22DBU970 22GBA195 22HBL094 22LBH829 23ABG503 23ABO274 23BBO056 23DBQ675 23FBQ670 23HBV115 23JBC749 23JBP144 DYNJ907758 UDI-DI 10193489872002 Lot 21FBF623 DYNJ40952 UDI-DI 10884389898826 Lot 21FBK360 DYNJ60715 UDI-DI 10193489520279 Lot 24ABO126 DYNJ37484B UDI-DI 10889942777792 Lots 21BDA459 21DDA549 21DDB648 21GDC975 21IDB972 21JDC475 21LDB205 22ADC256 22BDB581 22FDA100 22GDB220 22IDB953 22KDB836 23ADA661 23CDB420 23DDC200 DYNJ908706A UDI-DI 10195327406042 Lots 23FMI173 23GMB991 23HMF410 23IMF032 DYNJ0101339J UDI-DI 10193489472516 Lots 21BDA985 21DDB919 21GDD035 21HDC817 21KDA162 22ADA293 22BDB849 22EDB044 22HDB148 22IDC162 DYNJ69090 UDI-DI 10193489883596 Lots 21FMF068 22EMB610 DYNJ56260B UDI-DI 10193489569827 Lots 24ABR394
UPC codes
10193489925067, 10889942893645, 10193489352375, 10195327096991, 10889942249398, 10889942925421, 10193489409536, 10193489345230, 10193489459081, 10888277740273, 10889942952977, 10195327044138, 10193489688863, 10193489397482, 10193489345377, 10889942727919, 10888277762886, 10193489872002, 10884389898826, 10193489520279

Products covered by this recall

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYNDA2213A CUSTOM PROCEDURE KIT DYNJ65277A DEEP BRAIN STIMULATION PACK DYNJ0842793F HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918 INTERVENTIONAL PACK DYNJ56666B INVASIVE LINE INSERTION DYNJ44123A JUDKINS PACK DYNJ51126B LARKIN CUSTOM NEURO TRAY PAIN1454 MAJOR PLUS PACK DYNJ905160I MINIMALLY INVASIVE PACK-LF DYNJ0843063J NEURO ANGIO PACK SJF-LF DYNJ37304F NON-VASCULAR PACK DYNJ56386B OR HYBRID-MRMC DYNJ907758 PACER PACK DYNJ40952 PAIN PACK DYNJ60715 PICC PHC DYNJ37484B ROBOTIC PACK DYNJ908706A THORACOTOMY PACK-LF DYNJ0101339J DYNJ69090 VENOUS PACK DYNJ56260B

Check your product

The notice names 21 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.

  • 10193489925067
  • 10889942893645
  • 10193489352375
  • 10195327096991
  • 10889942249398
  • 10889942925421
  • 10193489409536
  • 10193489345230
  • 10193489459081
  • 10888277740273
  • 10889942952977
  • 10195327044138
  • 10193489688863
  • 10193489397482
  • 10193489345377
  • 10889942727919
  • 10888277762886
  • 10193489872002
  • 10884389898826
  • 10193489520279

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. 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.

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 10193489925067, 10889942893645, 10193489352375. 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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