Z-3074-2026Class II

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL...

Name: Z-3074-2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL...
Creator: Medline Industries, LP
Published: 2026-07-20
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-07-20 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP... on 2026-07-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3074-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-20
Posted: 2026-08-31
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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
Product code: OJU Skin Prep Tray
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 222,653 total
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3074-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3067-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3068-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3069-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3070-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3071-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3072-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3073-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3074-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3075-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3076-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3077-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3078-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3079-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31

Product code OJU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)