The Recall Desk

FDA (Devices) recall action 97154

MEDLINE INDUSTRIES, LP - Northfield recalled 4 products on 2025-07-30

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2025-07-30
Critical
0
Units
16,892

Why these products were recalled

Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2025-07-30

    Medline blood culture kits contain ChloraPrep applicators with open seals

    Medline blood culture convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 15,700 units affected.

    Product
    Medline 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.
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2025-07-30

    Medline IV start lab draw kits contain ChloraPrep with open seals

    Medline IV START KIT LAB DRAW-SH convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 184 units affected.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2025-07-30

    Medline C-section prep kits contain ChloraPrep applicators with open seals

    Medline C-SECTION PREP convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 48 units affected.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2025-07-30

    Medline labor triage kits contain ChloraPrep applicators with open seals

    Medline LABOR TRIAGE KIT convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 960 units affected.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
    Category
    Distribution
    4 states