# FDA recall Z-1089-2026

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

## Product

Medline medical procedure convenience kits labeled as:    1) LAVH PROCEDURE, REF CDS980754T;   2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q;   3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F;   4) LAVH, REF DYNJQ9041R;   5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I;   6) ROBOTIC LAVH, REF DYNJ901281I;   7) LAVH-LF, REF DYNJ901829T;   8) LEX LAP HYST, REF DYNJ902030J;   9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D;   10) GYN LAPAROSCOPY, REF DYNJ905485J;   11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C;   12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634;   13) LAVH GYN/ONC, REF DYNJ910927.

## 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-1089-2026
- **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-1089-2026

## Citation

> AI Analytics. FDA recall Z-1089-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1089-2026. Source: US FDA. Licensed CC0.

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