FDA Medical devices recall ·

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators… recall

Recall number
Z-3069-2026
Date
(initiated July 20, 2026)
Company / brand
Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States
Category
Medical devices › Class II
Classification
Class II
Status
Ongoing
Units affected
222,653 total
Hazard tags
Microbial contamination
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42828B EYE BASIN TRAY-LF DYNJ42832B

Why was it 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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

DYNJ42828B UDI-DI 10198459425516 Lots 25GBQ173 25HBB240 25JBD028 25LBL133 26ABU673 26CBN583 26EBD855 26FBO892; DYNJ42832B UDI-DI 10198459425530 Lots 25LBE548 26BBG040 26CBH272 26EBC041 26FBD497

Distribution

US Nationwide distribution.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-3069-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.