FDA-Device2026-07-29Class IIPROCESSING DEFECT
Medline medical convenience kits recalled for potential Bacillus contamination
What this means
Medline Industries is recalling three types of medical convenience kits (Shoulder Pack and Major Ortho Kit models) because the BD PurPrep solution included in them may contain low levels of Bacillus species bacteria. The contamination was discovered in specific lot numbers distributed across ten U.S. states.
- Check if you have one of the affected kits (SKU DYNJ39590O, DYNJ88566, or DYNJ911535) and verify the lot number on the package.
- Do not use the BD PurPrep 26 mL solution from the recalled kits.
- Contact Medline Industries or your medical supplier for instructions on returning or replacing the affected kits.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.
Affected count
398 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2789-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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