Medical device recalls Moderate risk

Medline Industries, LP recalls Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSI…

Recall date
December 24, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1334-2026
FDA classification
Class II
Brand / firm
Medline Industries, LP
Sold / distributed
US Nationwide distribution.

Why it was recalled

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495; 7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A; 8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B; 9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.

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