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-1887-2026
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
DYNJ34846C UDI-DI 10193489781441 (EA) 40193489781442 (CS) LOT 24BBA459 DYNJ83218A UDI-DI 10195327382308 (EA) 40195327382309 (CS) LOT 24BBD199 DYNJ85396 UDI-DI 10195327497613 (EA) 40195327497614 (CS) LOT 24BBA503 DYNJ905156R UDI-DI 10198459017704 (EA) 40198459017705 (CS) LOTS 24HBG726 24JBJ484 25ABS758 25BBR196 25CBN174 25EBE136 DYNJ905159L UDI-DI 10195327664251 (EA) 40195327664252 (CS) LOT 24EMB726 DYNJ905159M UDI-DI 10198459017735 (EA) 40198459017736 (CS) LOT 24GMA714 24HMD401 24HMJ945 24JMD201 24KMG592 25AMC024 25BMD945 25CMG373 DYNJ69926A UDI-DI 10195327153601 (EA) 40195327153602 (CS) LOT 24ABS445 DYNJ41250B UDI-DI 10888277801257 (EA) 40888277801258 (CS) LOT 24ABO122 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ905156R lots 24GBD135 24IBK563 24IBS862 25BBH767
UPC codes
10193489781441, 40193489781442, 10195327382308, 40195327382309, 10195327497613, 40195327497614, 10198459017704, 40198459017705, 10195327664251, 40195327664252, 10198459017735, 40198459017736, 10195327153601, 40195327153602, 10888277801257, 40888277801258

Products covered by this recall

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACK DYNJ41250B

Check your product

The notice names 24 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.

  • 10193489781441
  • 40193489781442
  • 10195327382308
  • 40195327382309
  • 10195327497613
  • 40195327497614
  • 10198459017704
  • 40198459017705
  • 10195327664251
  • 40195327664252
  • 10198459017735
  • 40198459017736
  • 10195327153601
  • 40195327153602
  • 10888277801257
  • 40888277801258

Lot or batch code

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

  • 24BBA459 DYNJ83218A UDI-DI 10195327382308
  • 24BBD199 DYNJ85396 UDI-DI 10195327497613
  • 24BBA503 DYNJ905156R UDI-DI 10198459017704
  • 24EMB726 DYNJ905159M UDI-DI 10198459017735
  • 24ABS445 DYNJ41250B UDI-DI 10888277801257
  • 24ABO122
  • 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. 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?

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 10193489781441, 40193489781442, 10195327382308; lot code 24BBA459 DYNJ83218A UDI-DI 10195327382308, 24BBD199 DYNJ85396 UDI-DI 10195327497613, 24BBA503 DYNJ905156R UDI-DI 10198459017704. 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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