CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report
Medline medical procedure convenience kits labeled as recalled
Medline Industries is recalling Medline medical procedure convenience kits labeled as: Kit Robotics Urology Prostate, distributed nationwide in the US. The recall was initiated on 16 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1090-2026
- FDA event ID
- 98197
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Dec 2025
- FDA classified
- 14 Jan 2026
- Reported
- 21 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 16 Dec 2025 | Recall initiated by company | |
| 14 Jan 2026 | Classified by FDA | +29 days |
| 21 Jan 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 98197| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Medline medical procedure convenience kits labeled as: Robotic recalled | Medline Industries | Packaging Defects | Nationwide |
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