Recall
FDAHealthDecember 16, 2025

Medline Industries, LP — Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
December 16, 2025

US Nationwide distribution.

What's affected?

Product
Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
Lot code
25EBD732

Additional details

1) UDI/DI 10198459269196 (EA) 40198459269197 (CS), Lot Number 25EBD732; 2) UDI/DI 10198459326318 (EA) 40198459326319 (CS), Lot Number 25FBA103.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 96 units.

View original FDA notice →

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