WhichRecall
Class IIReported 2026-01-21

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

Recalled by Medline Industries, LP

Reason for Recall

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

Advertisement

This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

Recall Number
Z-1085-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-12-16
Reported
2026-01-21
Distribution
US Nationwide distribution.
Code Info
1) UDI/DI 10198459269196 (EA) 40198459269197 (CS), Lot Number 25EBD732; 2) UDI/DI 10198459326318 (EA) 40198459326319 (CS), Lot Number 25FBA103.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
Advertisement