Class II U.S. Food and Drug Administration

Medline Industries, LP 1) Universal KIT, Kit SKU DT22010B recall: Medline Industries, LP is issuing a recall for specific items and lots

Recall published 8 months ago

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

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-1330-2026
Published
February 18, 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
21854 units
Distribution
Nationwide
Made in
United States
Lot / code info
1) Kit SKU DT22010B, UDI/DI 10653160351092, Lot number 25EBC888; 2) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBO566; 3) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBD964; 4) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBN178; 5) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBL624; 6) Kit SKU DYNDC2208C, UDI/DI 10889942815333, Lot number 25EBC706; 7) Kit SKU DYNDC3107, UDI/DI 10193489917628, Lot number 25EBN742; 8) Kit SKU DYNDH1029C, UDI/DI 10889942816453, Lot number 25EBC778; 9) Kit SKU UVT1250, UDI/DI 10653160995340, Lot number 25EBO757; 10) Kit SKU UVT835, UDI/DI 10653160289180, Lot number 25FMI300; 11) Kit SKU VAR101HVAA, UDI/DI 10193489388145, Lot number 25EBE079.
UPC codes
10653160351092, 10653160996965, 10198459005848, 10889942815333, 10193489917628, 10889942816453, 10653160995340, 10653160289180, 10193489388145

Products covered by this recall

1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit SKU DYNDC3107; 8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C; 9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250; 10) UMBILICAL VESSEL TRAY, Kit SKU UVT835; 11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA.

Check your product

The notice names 40 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.

  • 10653160351092
  • 10653160996965
  • 10198459005848
  • 10889942815333
  • 10193489917628
  • 10889942816453
  • 10653160995340
  • 10653160289180
  • 10193489388145

Lot or batch code

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

  • 25EBC888
  • 25EBO566
  • 25EBD964
  • 25EBN178
  • 25EBL624
  • 25EBC706
  • 25EBN742
  • 25EBC778
  • 25EBO757
  • 25FMI300
  • 25EBE079. — 21854 units

Model or item number

On the rating label, the box or the instruction sheet.

  • DT22010B
  • DT22790C
  • DYNDA2966A
  • DYNDC2208C
  • DYNDC3107
  • DYNDH1029C
  • UVT1250
  • UVT835
  • VAR101HVAA. — 1
  • UDI
  • DI 10653160351092
  • DI 10653160996965
  • DI 10198459005848
  • DI 10889942815333
  • DI 10193489917628
  • DI 10889942816453
  • DI 10653160995340
  • DI 10653160289180
  • VAR101HVAA
  • DI 10193489388145

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 Sterility

Medline Industries, LP — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  3. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  4. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

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?

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10653160351092, 10653160996965, 10198459005848; lot code 25EBC888, 25EBO566, 25EBD964; model number DT22010B, DT22790C, DYNDA2966A. 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?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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