FDA-Device2026-02-25Class IIPROCESSING DEFECT

Medline Admit Kit recalled for potential sterilization defect

OTHERNationwide distributionMedical devices

What this means

Medline has recalled certain batches of its Admit Kit (model DYKA1343A) due to calibration problems with the sterilization equipment used to package them. While the kits went through sterilization, the equipment issues may have affected how well they stayed sterile. No injuries have been reported.

  • Check if you have an Admit Kit model DYKA1343A with a lot number matching those listed in the recall
  • Do not use affected kits; contact your supplier or Medline for a replacement or instructions
  • If you have already used one of these kits, notify your healthcare provider
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The agency's original wording
Hazard

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide.
Affected count
1070 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1410-2026

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