Recall Z-1889-2026— Medline Industries, LP

Name: FDA recall Z-1889-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-27

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2026-02-27. It names one FDA 510(k) clearance: K020393. Product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J. Reason: Unapproved design changes to the products outside of the 510(k) clearance..

Recalling firm: Medline Industries, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-02-27
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K020393 — MASTER & FRANK SURGICAL DRAPES (STERILE)Master & Frank Enterprses Co., Ltd.·cleared 2002-05-03

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 containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J

Reason for recall

Unapproved design changes to the products outside of the 510(k) clearance.

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