Recall Z-3028-2026— Medline Industries, LP

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2026-07-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.. Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer.

Recalling firm
Medline Industries, LP
Classification
Class II
Status
Ongoing
Initiated
2026-07-10
Firm location
Northfield, IL, United States

Product description

Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.

Reason for recall

Kits contain a potentially contaminated component which were recalled by the manufacturer

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