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Medline Convenience Kits containing BD ChloraPrep Clear -… recallZ-3074-2026 · Medline Industries, LP · initiated Jul 20, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Firm began notifying consignees on 7/20/2026 via First-Class Mail and email. Medline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.

Recall details

Recall number
Z-3074-2026
Status
Open, Classified
Initiated by the company
Jul 20, 2026
Posted by the FDA
Aug 31, 2026
Recalling firm
Medline Industries, LP
Quantity
222,653 total
Product code
OJU
Distribution
US Nationwide distribution.

Product description

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B

Code information (models, lots, serial numbers)

DYKS2018 UDI-DI 10198459188480 Lot 25GMI043 DYKS1584A UDI-DI 10198459146633 Lots 24JBA740 25ABF244 DYKS1216I UDI-DI 10198459362668 Lots 25GBP888 25JBD789 26ABL474 26CBF334 26DBD640 26EBB855 26FBC632 DYKM1398B UDI-DI 10198459413827 Lots 25HBI183 25JBK222 25KBA990 25LBJ990 26BBI525 26CBJ249 26EBQ630 26FMF189

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 99561).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page