Recall Z-1881-2026— Medline Industries, LP

Name: FDA recall Z-1881-2026
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. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599. 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

Product description

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599

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.