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-1886-2026
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
DYNJ35056A UDI-DI 10889942227563 (EA) 40889942227564 (CS) LOT 24ABN639 DYNJ69318A UDI-DI 10195327370756 (EA) 40195327370757 (CS) LOTS 23DMD456 23EMB847 23HMB969 23IMC364 23JME011 23JMI841 23LMC384 24BMD333 24CMB768 24CMJ586 24EMJ527 24GMD970 24JMB408 24JMI594 24KMC774 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ69318A lots 23FMA845 23FMA924 25BMF603
UPC codes
10889942227563, 40889942227564, 10195327370756, 40195327370757

Products covered by this recall

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A

Check your product

The notice names 7 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.

  • 10889942227563
  • 40889942227564
  • 10195327370756
  • 40195327370757

Lot or batch code

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

  • 24ABN639 DYNJ69318A UDI-DI 10195327370756
  • 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 — 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. 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.

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 10889942227563, 40889942227564, 10195327370756; lot code 24ABN639 DYNJ69318A UDI-DI 10195327370756, 311 total. 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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