Recall Z-0137-2026— Medline Industries, LP

Name: FDA recall Z-0137-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-10

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2025-09-10. It names one FDA 510(k) clearance: K213481. Product: Medline Adult Anesthesia Set, REF DYNJ39985G. Reason: Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking..

Recalling firm: Medline Industries, LP
Classification: Class II
Status: Ongoing
Initiated: 2025-09-10
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K213481 — Medline General Surgery TrayMedline Industries, Inc.·cleared 2022-05-24

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 Adult Anesthesia Set, REF DYNJ39985G

Reason for recall

Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.

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