Recall Ledger

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT... recall (Medline Industries, LP)

Medical deviceClass IIOngoing

Summary: Medline Industries, LP is recalling Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A. Reason: 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.

What is being recalled

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution.

How to tell if yours is affected

DYKS1583A UDI-DI 10198459146640 Lot 24KBP388

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-3078-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJuly 20, 2026
ReportedSeptember 9, 2026
CompanyMedline Industries, LP
Company locationNorthfield, IL, United States
Initiated byVoluntary: Firm initiated
Quantity222,653 total

More recalls from Medline Industries, LP · all medical device recalls · recalls from July 2026

Official FDA record