# FDA recall Z-1088-2026

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

## Product

Medline medical procedure convenience kits labeled as:    1) ROBOTIC, REF CDS980523M;   2) ROBOTIC GYN, REF CDS980647K;   3) DAVINCI PROCEDURE, REF CDS980864Q;   4) GYN-URO LAPSCP CDS-LF, REF CDS981583U;   5) GYN-URO LAPSCP CDS-LF, REF CDS981583V;   6) GYN ROBOTIC, REF CDS981826K;   7) DEPAUL DAVINCI CDS, REF CDS982377K;   8) GU DAVINCI, REF CDS982779N;   9) GYN DAVINCI, REF CDS982780V;   10) UNIVERSAL ROBOTIC ORLANDO, REF CDS982857K;   11) ROBOTIC GU/GYN, REF CDS983393L;   12) GYN LAPAROSCOPY CDS, REF CDS984656Q;   13) GYN LAPAROSCOPY CDS, REF CDS984656R;   14) DAVINCI CDS UCC-LF, REF CDS984663J;   15) ROBOTIC UROLOGY PROSTATE, REF CDS985467J;   16) DAVINCI PROSTATECTOMY, REF DYNJG901002B;   17) ROBOTIC PACK IMF 100913- LF, REF DYNJVB91075C;   18) ROBOTIC PACK, REF DYNJ36840L;   19) ROBOTIC PACK MNMC, REF DYNJ38152D;   20) WMC GYN LAPAROSCOPY PACK-LF, REF DYNJ50649J;   21) ROBOTIC GASTRIC BYPASS PACK, REF DYNJ52096P;   22) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564D;   23) SCRIPPS SW ROBO

## 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-1088-2026
- **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-1088-2026

## Citation

> AI Analytics. FDA recall Z-1088-2026. Retrieved 2026-07-29 from https://api.ai-analytics.org/recall/Z-1088-2026. Source: US FDA. Licensed CC0.

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