FDA Device recall Z-1090-2026
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
- FDA Device
- Class II
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class II recall of Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G by Medline Industries, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1090-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-16 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Reason
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.
Identifiers
| code_info | UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1090-2026%22
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