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

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: 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-1891-2026
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
00-402001T UDI-DI 10193489939682 (EA) 40193489939683 (CS) LOTS 23EBT729 23GBR995 23GBS336 00-402001U UDI-DI 10195327517380 (EA) 40195327517381 (CS) LOTS 23JBU819 23LBG449 24ABS585 24CBF190 24DBA960 24EBB048 24FBN231 24HBA892 24IBD316 24IBS824 DYNJ60329A UDI-DI 10193489972221 (EA) 40193489972222 (CS) LOT 24ABP714 CVI5070 UDI-DI 10195327526061 (EA) 40195327526062 (CS) LOT 24FBF359 DYNJ66259 UDI-DI 10193489325485 (EA) 40193489325486 (CS) LOT 22FMB867 DYNJ44123C UDI-DI 10195327599140 (EA) 40195327599141 (CS) LOTS 24ABQ097 24DMH637 24FMG692 24GMA523 24HME792 24JMA878 24JMI393 DYNJ68037B UDI-DI 10195327476458 (EA) 40195327476459 (CS) LOT 24HBK116 DYNJ68037C UDI-DI 10198459239328 (EA) 40198459239329 (CS) LOT 25BBO522 25DBR880 DYNJ0774005G UDI-DI 10193489271485 (EA) 40193489271486 (CS) LOTS 23DMC237 23EMC431 23FMG987 23HBL979 23JBG840 23KBJ401 23LBR858 24CBB784 24EBA777 DYNJ47717B UDI-DI 10195327355302 (EA) 40195327355303 (CS) LOTS 23GMB288 23HMA341 23HMH322 DYNJ37484C UDI-DI 10195327397340 (EA) 40195327397341 (CS) LOTS 24EDB695 24HDC050 24IMH716 24JMH721 24KMG262 ***Updated 5/20/26 - The following lots were included in the customer notification but not the FDA submission.*** 00-402001T Lots 21GBL509 21JBN647 21JBZ697 22BBX248 22DBL467 22DBS962 22GBC939 22HBO291 22HBO322 22IBN444 22IBO023 22KBT315 23BBA151 23CBI235 23DBM140; DYNJ0774005G Lots 21AMC932 21CMB295 21EMA842 21EMA842Z 21GME190 21IMF074 21JMA971 22AMB224 22CMF849 22CMG025 22DMF774 22HMD145 22HMH991 22JMF788 23AMH034 23CMA447; DYNJ37484C Lots 23EDA007 23GDA068 23HDC049 23JDA140 23LDA212 24BDA222 24DDA235 25AMA456 25AMH943; DYNJ44123C Lots 25BMC026; DYNJ47717B Lots 23DME176; DYNJ68037B Lots 23JBM013 23LBR847 24CBM608 24DBQ050 24HBT816 25ABA997
UPC codes
10193489939682, 40193489939683, 10195327517380, 40195327517381, 10193489972221, 40193489972222, 10195327526061, 40195327526062, 10193489325485, 40193489325486, 10195327599140, 40195327599141, 10195327476458, 40195327476459, 10198459239328, 40198459239329, 10193489271485, 40193489271486, 10195327355302, 40195327355303

Products covered by this recall

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEIN PROCEDURES DYNJ60329A CENTRAL VENOUS ACCESS PACK-LF CVI5070 FISTULAGRAM PACK DYNJ66259 INVASIVE LINE INSERTION DYNJ44123C NON VASCULAR PACK DYNJ68037B, DYNJ68037C PICC ABSCESS PACK-LF DYNJ0774005G PICC LINEPACK (PCLUI)642-LF DYNJ47717B PICC PHC DYNJ37484C

Check your product

The notice names 28 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.

  • 10193489939682
  • 40193489939683
  • 10195327517380
  • 40195327517381
  • 10193489972221
  • 40193489972222
  • 10195327526061
  • 40195327526062
  • 10193489325485
  • 40193489325486
  • 10195327599140
  • 40195327599141
  • 10195327476458
  • 40195327476459
  • 10198459239328
  • 40198459239329
  • 10193489271485
  • 40193489271486
  • 10195327355302
  • 40195327355303

Lot or batch code

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

  • 24ABP714 CVI5070 UDI-DI 10195327526061
  • 24FBF359 DYNJ66259 UDI-DI 10193489325485
  • 22FMB867 DYNJ44123C UDI-DI 10195327599140
  • 24HBK116 DYNJ68037C UDI-DI 10198459239328
  • 25BMC026
  • 23DME176
  • 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 — 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. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.
  3. Keep a photo of the mismatched label, which makes the refund conversation much shorter.
  4. Check the lot code on your pack — these mix-ups are usually confined to a short production window.

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?

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 10193489939682, 40193489939683, 10195327517380; lot code 24ABP714 CVI5070 UDI-DI 10195327526061, 24FBF359 DYNJ66259 UDI-DI 10193489325485, 22FMB867 DYNJ44123C UDI-DI 10195327599140. 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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