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Open, Classified

Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108

FDA Recall Z-1328-2026 · Posted 2026-02-09

Recall StatusOpen, Classified
Product CodeOEZ
Date Initiated2025-12-24
Product Quantity450 kits

Reason for Recall

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.

Firm Action

Medline issued an URGENT MEDICAL DEVICE recall notice to its consignees on 12/24/2025 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the consignee locate and quarantine the affected units and respond to the notice using the website link: https://recalls.medline.com; Recall Reference #: R-25-257-FGX1, and the specific code listed in the notice. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. Distributors and those who further distributed the affected its were directed to notify those to whom the kits were distributed or transferred, and include those quantities on the response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

Root Cause

Packaging change control

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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