Class II U.S. Food and Drug Administration

Medline recall: Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific

Recall published last month

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3073-2026
Published
September 9, 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
222,653 total
Distribution
Nationwide
Made in
United States
Lot / code info
DYNDH1444D UDI-DI 10195327502492 Lots 24IBK133 24KBE072 24LBD419 25GBT189 25IME347 25IMI389 25KMA880 25KME693 26BMH685 26CMH411 26DME199 26EMB070 26EMF542 26FMC275 DYNDH1866 UDI-DI 10195327400958 Lots 24HBW237 24IBI505 24JBI308 24KBH534 24LBI545 25ABC487 25ABO282 DYNDH1462B UDI-DI 10195327662462 Lots 24HBV192 24IBE469 24IBV947 24JBA557 24JBI310 24KBJ830 24KBJ831 24KBN934 24LBN283 24LBP258 DYNDH1622C UDI-DI 10195327509873 Lots 24IBE381 24IBL908 24JBF575 24JBS022 24KBN937 24LBI552 DYNDH1622D UDI-DI 10198459234965 Lots 25GBA905 25GBI398 25GBT182 25HBN203 25IBH345 25IBQ486 25IBS192 25JBN629 25KBK718 25LBI568 DYNDH1622F UDI-DI 10198459658884 Lots 26BBL477 26CBA407 26CBD376 26DBA855 26DBL286 26FBF458 DYNDH1715B UDI-DI 10195327407094 Lot 24IMF148 DYNDH2028 UDI-DI 10198459035715 Lot 24KBL250 DYNDH2048 UDI-DI 10198459106125 Lots 24JBK987 25GBI401 25GBT183 25IBB666 25JBC742 25KBD093 25KBK723 25LBI567 25LBO863 26ABL653 26CBO165 26DBB153 26DBE994 26EBF752 26FBN334 DYNDH2089 UDI-DI 10198459244070 Lots 25KMJ967 26BMI731 26FMF126 DYLAB1081 UDI-DI 10198459199608 Lots 24LMH506 25HMA386 25HMD685 25IMF415 25JMB438 25JMC503 26AML138 26BMJ277 26EMB352 DYLAB1080 UDI-DI 10198459199615 Lots 24LMG085 25AMH560 DYNDH1445C UDI-DI 10195327502614 Lots 24IBK131 24KBB551 24LBU139 25GBQ023 25GBU016 25HMI515 25IMB465 25IME350 25JMI247 26CMB609 26DMH686 26FMC274 26FMC274D DYNDH2350 UDI-DI 10198459779251 Lot 26FBM766 DYNDH2093 UDI-DI 10198459256967 Lot 26ABP408
UPC codes
10195327502492, 10195327400958, 10195327662462, 10195327509873, 10198459234965, 10198459658884, 10195327407094, 10198459035715, 10198459106125, 10198459244070, 10198459199608, 10198459199615, 10195327502614, 10198459779251, 10198459256967

Products covered by this recall

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE DYNDH1866 BLOOD CULTURE KIT DYNDH1462B DYNDH1622C DYNDH1622D DYNDH1622F DYNDH1715B DYNDH2028 DYNDH2048 BLOOD CULTURE-NB DYNDH2089 BLOOD DRAW KIT DYLAB1081 FLOORS BLOOD DRAW KIT DYLAB1080 PEDS BLOOD CULTURE KIT DYNDH1445C PERIPHERAL BLOOD CULTURE KIT DYNDH2350 WICHITA BLOOD CULTURE COLLECT DYNDH2093

Check your product

The notice names 17 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.

  • 10195327502492
  • 10195327400958
  • 10195327662462
  • 10195327509873
  • 10198459234965
  • 10198459658884
  • 10195327407094
  • 10198459035715
  • 10198459106125
  • 10198459244070
  • 10198459199608
  • 10198459199615
  • 10195327502614
  • 10198459779251
  • 10198459256967

Lot or batch code

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

  • 653 total

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 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 Device

Medline Industries, LP — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

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?

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10195327502492, 10195327400958, 10195327662462; lot code 653 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?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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