FDA-Device2026-02-25Class IIPROCESSING DEFECT

Medline arthroscopy surgical kits recalled for sterilization calibration issues

OTHERNationwide distribution

Check Medline arthroscopy kits for sterilization defects

Medline discovered that equipment used to sterilize and package certain arthroscopy surgical kits had calibration problems. While the kits went through sterilization, the equipment issues may have affected whether the products met required sterility standards. No injuries have been reported.

  • Check if you have any of the affected Medline arthroscopy kits by model number (CDS984609B, DYNJ22501G, DYNJ32715F, DYNJ50834C, or DYNJ51069) and lot number
  • Contact Medline Industries if you have an affected kit and follow their instructions for return or replacement
  • Do not use recalled kits until you confirm they are not on the recall 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
175 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1422-2026

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