FDA-Device2026-03-04Class IIPROCESSING DEFECT
Medline Convenience Kits recalled for sterile saline wound wash not meeting sterility standards
OTHERNationwide distribution
Stop using Medline Convenience Kits
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
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.
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 Industries, LP recalls
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
- FDA-Device2026-07-29Medline medical procedure kits recalled for pain medication quality issues
- FDA-Device2026-07-29Medline urology robotic procedure packs recalled for defective Bard Silastic Foley Catheters
- FDA-Device2026-07-29Medline medical convenience kits recalled for potential Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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