FDA-Device2026-02-25Class IIPROCESSING DEFECT

Medline surgical packs recalled due to sterilization equipment calibration issue

OTHERNationwide distribution

Check your Medline surgical packs

Medline Industries identified calibration problems with equipment used to sterilize and package certain surgical packs. While the packs went through the standard sterilization process, the equipment issues may have affected their sterility. This recall affects specific lot numbers of Universal UltraGard and Shoulder Drape Pouch surgical packs.

  • Check if you have any recalled Medline surgical packs by lot number
  • Do not use recalled packs for sterile procedures
  • Contact Medline Industries or your supplier for instructions on return or replacement
  • Review FDA recall notice for complete lot number list
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
193157 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1425-2026

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