Recall Z-1432-2026— Medline Industries, LP

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2026-01-05. It names one FDA 510(k) clearance: K112666. Product: Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214. Reason: Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products..

Recalling firm
Medline Industries, LP
Classification
Class II
Status
Ongoing
Initiated
2026-01-05
Firm location
Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214

Reason for recall

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

Data sourced from openFDA. This site is unofficial and independent of the FDA.