Medline Industries Recalls Over 10,000 Convenience Kits Due to Sterility Concerns

FDA Recalls high FDA · · United States, Bahamas, Bermuda, Cayman Islands

Medline Industries, LP has issued a voluntary recall for several models of its convenience kits because the included sterile saline wound wash may not meet sterility standards.

What Happened

Medline Industries, LP has initiated a voluntary recall of several Medline Convenience Kits. The company identified that the manufacturer of the sterile saline wound wash included in these kits may not have met the minimum required sterility assurance levels necessary for sterile medical products.

Which Products Are Affected

The recall affects approximately 10,550 units distributed nationwide in the United States, as well as in the Bahamas, Bermuda, and the Cayman Islands. The following Medline Convenience Kits (Trunk Kits) are included:

  • TRUNK KIT W/EXPIRATION: Model DYKM1361A (Lots: 25JBG340, 25EBV829, 25CBM029, 25BBI797, 25ABW687)
  • TRUNK KIT 1EA: Model DYKM2013 (Lots: 23EBN045, 23DBM064)
  • TRUNK KIT 1EA: Model DYKM2013A (Lots: 25HBB845, 25GBS259, 25DBR145, 25BBS769, 24KBJ466, 24JBQ815, 24IBU526, 23IBJ540, 23HBP844, 23HBE308, 23GBT102)
  • RN TRUNK KIT: Model DYKM2699 (Lots: 25DLA344, 25CLA657, 24GLB208, 24ELA332)
  • TRUNK KIT: Model DYKTRUNK1 (Multiple lots including 25HBS451, 25HBS450, 25HBE908, 25HBE909, 25GBM037, 25GBK565, 25FBL177, 25EBP727, 25EBO749, 25DBQ021, 25DBD942, 25DBA345, 25BBU730, 25BBS503, 25ABM247, 24KBN725, 24KBE264, 24IBH956, 24IBH955, 24IBH957, 24HBQ854, 24HBO200, 24GBN624, 24FBH929, 24FBG790, 24FBD096, 24DBS507, 24DBC075, 24CBG460, 24ABO402, 23LBU172, 23KBK857, 23KBJ794, 23JBM608, 23IBQ747, 23IBO843, 23IBO844, 23HBT781, 23FBK991, 23FBC676, 23EBG472, 23CBW700, 23CBM546)

The recall is identified by FDA Recall Number Z-1433-2026.

What You Should Do

Medline Industries initiated the recall notification via letter on January 5, 2026. Consumers and healthcare providers in possession of the affected kits should immediately check their inventory for the model and lot numbers listed above. For further information regarding the recall, contact Medline Industries, LP at their Northfield, IL headquarters.

Why This Matters

The failure to meet sterility assurance levels in medical products like wound wash can lead to serious infections or other health complications for patients.

Source

Information provided by the FDA.

Source: FDA Official Notice

Frequently Asked Questions

What is this fda recalls alert about?
Medline Industries, LP has issued a voluntary recall for several models of its convenience kits because the included sterile saline wound wash may not meet sterility standards.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States, Bahamas, Bermuda, Cayman Islands. Check with FDA for the most current geographic scope.
Where can I find more fda recalls alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.