# FDA recall Z-0643-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-10-09.

## Product

MEDLINE convenience kits labeled as:    1) GYN LAPAROSCOPY-LF, REF CDS760059I;   2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S;   3) GYN MAJOR, REF CDS980998L;   4) ROBOTIC PROCEDURE, REF CDS982128P;   5) ROBOTIC, REF CDS984262N;   6) GYN LAPAROSCOPY, REF CDS984900M;   7) GYN LAPAROSCOPY, REF CDS984900N;   8) DAVINCI PACK-LF, REF DYNJ0101304G;   9) PROSTATE ROBOTIC PACK, REF DYNJ0347372J;   10) URO GYN PACK-LF, REF DYNJ17454N;   11) DB DAVINCI ROBOT PACK-LF, REF DYNJ33592I;   12) ROBOTIC UROLOGY-RF, REF DYNJ38844N;   13) TLH PACK, REF DYNJ42792D;   14) SVMMC GEN ROBOTIC PACK, REF DYNJ43770L;   15) SVMMC ROBOTIC KIDNEY PACK, REF DYNJ43778L;   16) SVMMC GYN ROBOTIC PACK, REF DYNJ43782K;   17) SVMMC ROBOTIC PROSTATE PACK, REF DYNJ43862J;   18) DA VINCI HYSTERECTOMY, REF DYNJ44863O;   19) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S;   20) LAP-GYN PACK, REF DYNJ44876L;   21) LAP-GYN PACK, REF DYNJ44876M;   22) ROBOT PACK, REF DYNJ45184F;   23) GYN ROBOTIC PACK, REF DYNJ47766Q;   24) ST. ANN

## Reason for recall

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0643-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-09
- **Report date:** 2024-12-11

- **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-0643-2025

## Citation

> AI Analytics. FDA recall Z-0643-2025. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0643-2025. Source: US FDA. Licensed CC0.

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