# FDA recall Z-1087-2026

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

## Product

Medline medical procedure convenience kits labeled as:    1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF;   2) ROBOTIC PROCEDURE, REF CDS982128Q;   3) CUH THORACIC, REF CDS984338M;   4) THORACIC PROCEDURE, REF CDS984640I;   5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O;   6) LAP CHOLE PACK, REF DYNJ57640F;   7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D;   8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D;   9) LAPAROSCOPY PACK, REF DYNJ68187B;   10) LAPAROSCOPY PACK, REF DYNJ82368A;   11) ROBOTIC KIDNEY PACK, REF DYNJ85261;   12) DOWNTOWN ROBOTICS, REF DYNJ86178B;   13) DAVINCI LITHOTOMY PACK, REF DYNJ87610;   14) ROBOTIC WHIPPLE PACK, REF DYNJ88433;   15) PROSTATE DAVINCI, REF DYNJ900127G;   16) GENERAL LAPAROSCOPY, REF DYNJ901847M;   17) LAG TLH, REF DYNJ901890N;   18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S;   19) LAP, REF DYNJ904576B;   20) ROBOTIC, REF DYNJ905147B;   21) ROBOTICS GYN, REF DYNJ905824M;   22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B;   23) CHN OR BASIC ROBOTIC, REF DYNJ

## 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-1087-2026
- **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-1087-2026

## Citation

> AI Analytics. FDA recall Z-1087-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1087-2026. Source: US FDA. Licensed CC0.

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