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Lower risk Medical device recall · FDA · Published June 12, 2025

Medline Convenience Kits Recall: Risk of Sterility Breach from Open Packaging

Medline recalls convenience kits with BD ChloraPrep Clear 1mL applicators that may have open packaging, risking sterility breaches and patient infections. Affected kits include specific blood culture kit references and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2155-2025Medical deviceMedline ›
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Contact the company

Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

Medline is recalling convenience kits containing BD ChloraPrep Clear 1mL applicators that were previously recalled by BD for potential open packaging. This could breach sterility and lead to patient infections if used. Read more at govinfonow.com/recall/52044-medline-convenience-kits-recall-risk-of-sterility-breach-from-open.

Source Summary by GovInfoNow · govinfonow.com/recall/52044-medline-convenience-kits-recall-risk-of-sterility-breach-from-open · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2155-2025

Cite this page

“Medline Convenience Kits Recall: Risk of Sterility Breach from Open Packaging.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52044-medline-convenience-kits-recall-risk-of-sterility-breach-from-open. Based on FDA recall #Z-2155-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2155-2025%22&limit=1).

The FDA announced on June 12, 2025, that Medline Industries LP is recalling Medline Convenience Kits containing BD ChloraPrep Clear applicators due to potential sterility breaches. The agency stated the recall affects approximately 15,700 units distributed in California, Florida, Pennsylvania, and Texas.

How to tell if you have it

  • Brand: Medline
  • Product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicator
  • REF DYNDH1462B (Lot Numbers: 24EBU164, 24FBD281, 24FBK195)
  • REF DYNDH1622C (Lot Number: 24EBU004)
  • REF DYNDH1866 (Lot Number: 24EBT285)

The hazard

The affected kits contain BD ChloraPrep Clear - 1 mL Applicators that may exhibit an open seal on their packaging. This defect constitutes a breach to sterility, which may lead to infection-related harms for the patient.

Context

GovInfoNow's records show MEDLINE INDUSTRIES, LP - Northfield has issued 119 other recalls since October 22, 2021. Recent recalls include Medline medical kits with light failure in newborn resuscitation kits (July 25, 2025), Foley Tray Kits with incorrect labeling risk (July 23, 2025), and RepNewal Reprocessed St. Jude Catheters that may contain particulates (July 14, 2025). Other recent recalls of similar products include Medline Convenience Kits Recall: Potential Sterility Breach in Packaging (June 12, 2026), Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026), and Medline Convenience Kits Recall: Sterile Packaging Risk (June 12, 2026).

How to tell if you have this one

Check for kits labeled as blood culture kits with references DYNDH1462B, DYNDH1622C, or DYNDH1866. Look for lot numbers 24EBU164, 24FBD281, 24FBK195, 24EBU004, or 24EBT285.

  • Brand
    Medline
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
Recall numberProduct, codes & lotsQuantity
Z-2153-2025Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564; UDI/DI 10889942754571 (EA), 40889942754572 (CASE), Lot Numbers: 24EBR566960 units
Z-2154-2025Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P; UDI/DI 10888277797819 (EA), 40888277797810 (CASE), Lot Numbers: 24EBR549184 units
Z-2155-2025Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.; 1) REF DYNDH1462B: UDI/DI 10195327662462 (EA), 40195327662463 (CASE), Lot Numbers: 24EBU164, 24FBD281, 24FBK195; 2) REF DYNDH1622C: UDI/DI 10195327509873 (EA), 40195327509874 (CASE), Lot Numbers: 24EBU004; 3) REF DYNDH1866: UDI/DI 10195327400958 (EA), 40195327400959 (CASE), Lot Numbers: 24EBT285.15700 units
Z-2156-2025Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B; UDI/DI 10193489431070 (EA), 40193489431071 (CASE), Lot Numbers: 24EBR76148 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Labels

    Look for kit references DYNDH1462B, DYNDH1622C, or DYNDH1866 and associated lot numbers to confirm if your kit is affected.

Where it went and when

Where it was distributed

Distributed in 4 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Pennsylvania, Texas.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Jun 12, 202512. FDA classified it Class II: Jul 21, 202523. Published in FDA’s Enforcement Report: Jul 30, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these kits immediately?

The recall does not require immediate stop use; affected kits should be checked for the specific references and lot numbers.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2155-2025 (June 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2155-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA