Robotic prostate kits recalled over suction irrigators that can leak
Medline is recalling 12 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites leakage and vapour emission from a kit component with no stated patient harm or reported injury.
Plain-English summary
Medline medical procedure convenience kits are being recalled by Medline Industries, LP, covering the Kit Robotics Urology Prostate under REF DYKMBNDL116G.
The kits contain Stryker's Strykeflow 2 Suction Irrigators. The record states that 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, and that this design change has caused some devices to leak and/or emit vaporized saline, which can resemble smoke, during use.
The record lists 12 units, with REF numbers, UDI/DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The record describes leakage and vapour emission and states no further consequence or reported injuries. Facilities should quarantine affected kits and follow Medline's instructions.
The recalled product
- Product
- Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 12
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 (2)
- UDI/DI 10198459156991 (EA) 40198459156992 (CS)
- Lot Number 25EBM426
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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