FDA-Device2026-02-25Class IIPROCESSING DEFECT

Medline Convenience Kits recalled for potential sterility issues from equipment calibration

OTHERNationwide distribution

Return Medline Convenience Kits to your supplier

Medline has recalled several medical convenience kits used for pain management and nerve block procedures due to calibration problems with sterilization equipment. While the products went through sterilization cycles, calibration issues could affect whether the devices are truly sterile. No injuries have been reported.

  • Check if you have any Medline Convenience Kits (SCC RF PAIN MGMT or CPNB SETUP TRAY models listed in the recall) with the affected lot numbers
  • Stop using affected products immediately
  • Contact your Medline supplier or distributor for return instructions
  • Do not open or use any recalled kits
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
779 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1386-2026

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