Medline thoracic and cardiac robotic surgery kits recalled for leaking Strykeflow 2 suction irrigators
What this means
Medline medical procedure kits containing Stryker Strykeflow 2 Suction Irrigators have a design flaw that allows irrigation fluid to leak into the handpiece and battery pack during use. Some devices have leaked or released vaporized saline that may resemble smoke. This affects specific thoracic and cardiac robotic surgery kits distributed nationwide.
- Check if you have Medline thoracic robotics kit (REF DYNJ908777B, Lot 25EBD732) or cardiac robotic kit (REF DYNJ911359, Lot 25FBA103)
- Do not use affected kits during medical procedures
- Contact Medline Industries directly for replacement or instructions
The agency's original wording
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1085-2026More 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.