FDA-Device2026-02-25Class IIPROCESSING DEFECT

Medline Convenience Kits chest/breast-LF recalled for potential sterility issues

OTHERNationwide distribution

Check Medline Convenience Kit lot numbers

Medline Industries has recalled certain Chest/Breast-LF Convenience Kits (Model DYNJ83950) because equipment used to sterilize and package them had calibration problems. While the kits went through sterilization cycles, the calibration issues may have affected whether they meet required sterility standards. No injuries have been reported.

  • Check if you have a Medline Convenience Kit Model DYNJ83950 with lot numbers 24DBT832, 24CBH626, 23LBR075, 23FBF248, or 23CBG610
  • Stop using any kits matching these lot numbers
  • Contact Medline Industries or your supplier for instructions on return or replacement
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
150 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1412-2026

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