Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2
Pending LLM rewrite. Source: FDA_DEVICE Z-1085-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 1) UDI/DI 10198459269196 (EA) 40198459269197 (CS)
- Lot Number 25EBD732
- 2) UDI/DI 10198459326318 (EA) 40198459326319 (CS)
- Lot Number 25FBA103.
Distribution
Distributed nationwide across the United States.
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