Medline Convenience Kits containing BD ChloraPrep Clear -… recallZ-3076-2026 · Medline Industries, LP · initiated Jul 20, 2026
Open, Classified
Is my device affected?
- 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.
- 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.
- 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-3076-2026
- 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
- MLS
- Distribution
- US Nationwide distribution.
Product description
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F
Code information (models, lots, serial numbers)
CDS981762B UDI-DI 10193489306767 Lots 24JBE456 24JBN932 24KBJ154 25ABK513 25CBL684 25HBK086 25IBM188 25KBL720 25LBF812 25LBU497 26ABM665 26CBH544 26CBT272 26FBK806 DYKA1054F UDI-DI 10193489312607 Lots 24ILA823 24JLA285 24LLA226 24LLB033 25BLA842 25ELA624 25GLA270 25HLB055 25KLA019 25KLA187 26BLA150 26CLA717 26DLA410 26ELA772 26FLA756
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. CDS981762BMedline Industries, Inc. · Labor and Delivery Kit2 recalls0 reports
- Medline Industries, Inc. DYKA1054FMedline Industries, Inc. · Labor and Delivery Kit2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99561).
- Z-3067-2026 · Open, ClassifiedMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A
- Z-3068-2026 · Open, ClassifiedMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
- Z-3069-2026 · Open, ClassifiedMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42828B EYE BASIN TRAY-LF DYNJ42832B
- Z-3070-2026 · Open, ClassifiedMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER…
- Z-3071-2026 · Open, ClassifiedMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV START KIT LAB DRAW-SH CDS860014P U…
- Z-3072-2026 · Open, ClassifiedMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/CONNECT DYNDH1487A
- Z-3073-2026 · Open, ClassifiedMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE DYNDH1866 BLOOD CULTURE KIT DYNDH…
- Z-3074-2026 · Open, ClassifiedMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM13…
- Z-3077-2026 · Open, ClassifiedMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B
- Z-3078-2026 · Open, ClassifiedMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A
- Z-3079-2026 · Open, ClassifiedMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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