Medline arthroscopy surgical kits recalled for sterilization calibration issues
What this means
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
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1422-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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