FDA-Device2026-02-25Class IIPROCESSING DEFECT

Medline Admit Kit recalled for potential sterilization defect

OTHERNationwide distribution

Stop using Medline Admit Kit DYKA1343A

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
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.

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

More Medline Industries, LP recalls

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief