Recall Z-2789-2026— Medline Industries, LP

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2026-06-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.. Reason: Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species..

Recalling firm
Medline Industries, LP
Classification
Class II
Status
Ongoing
Initiated
2026-06-11
Firm location
Northfield, IL, United States

Product description

Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.

Reason for recall

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

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