Recall Z-3209-2026— Medline Industries, LP

Name: FDA recall Z-3209-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2026-07-31. It names one FDA 510(k) clearance: K213481. Product: Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A. Reason: Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used..

Recalling firm: Medline Industries, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-07-31
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

Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A

Reason for recall

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

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