Official recall record
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-12-16
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10198459156991
- Brand on record
- Medline Industries, LP
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2026-06-08 · US FDA — Medical Devices
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOT
Other recalls from this brand
- 2026-08-14 · US FDA — Medical Devices
Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medica - 2026-08-14 · US FDA — Medical Devices
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Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/
All 257 official recall notices naming Medline Industries, LP on this site →