FDA-Device2026-01-21Class IIPROCESSING DEFECT

Medline thoracic and cardiac robotic surgery kits recalled for leaking Strykeflow 2 suction irrigators

BURNELECTRICAL SHOCKNationwide distribution

Stop using affected Medline robotic surgery kits

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
Hazard

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.

Sold states
US Nationwide distribution.
Affected count
96 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1085-2026

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