FDA DevicesClass II
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PRO...
Published: January 21, 2026Recall ID: Z-1090-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Affected Products
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98197 |
| Address 1 | 3 Lakes Dr |
| Code info | UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426 |
| Postal code | 60093-2753 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 12 units |
| 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. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251216 |
| Initial firm notification | Letter |
| Center classification date | 20260114 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.