# FDA recall Z-1085-2026

> **Medline Industries, LP** · Class II · device recall initiated 2025-12-16.

## Product

Medline medical procedure convenience kits labeled as:    1) THORACIC ROBOTICS, REF DYNJ908777B;   2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1085-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-16
- **Report date:** 2026-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1085-2026

## Citation

> AI Analytics. FDA recall Z-1085-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1085-2026. Source: US FDA. Licensed CC0.

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