FDA-Device2026-03-04Class IIPROCESSING DEFECT
Medline Convenience Kits recalled for sterile saline wound wash not meeting sterility standards
What this means
Medline recalled five models of Convenience Kits because the sterile saline wound wash component may not meet required sterility safety standards. The affected kits were distributed for medical use. No injuries have been reported.
- Check if you have one of the recalled kit models: DYKM1361A, DYKM2013, DYKM2013A, DYKM2699, or DYKTRUNK1
- Stop using the saline wound wash in these kits
- Contact Medline Industries for instructions on return or replacement
- Check the lot number on your kit against the FDA recall list
The agency's original wording
Hazard
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
Affected count
10550 units (495 additional units 3/27/26)
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1433-2026More 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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