# FDA recall Z-0646-2025

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

## Product

MEDLINE convenience kits labeled as:    1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G;   2) LAVH CDS, REF CDS983411J;   3) MAJOR VAGINAL, REF CDS983497L;   4) DAY SURG LARGE VAG CDS, REF CDS984995N;   5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F;   6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M;   7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K;   8) VAG HYST PACK-LF, REF DYNJ0532873M;   9) VAG HYST PACK-LF, REF DYNJ0532873N;   10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q;   11) MINOR VAGINAL #76-RF, REF DYNJ27434R;   12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I;   13) VAG HYST PACK, REF DYNJ36628L;   14) VAG HYST PACK, REF DYNJ36628M;   15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F;   16) ABDOMINAL HYST PACK, REF DYNJ44848L;   17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q;   18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O;   19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P;   20) URO GYN, REF DYNJ50047G;   21) LAVH NEW BRAUNFELS, REF DYNJ61136D;   22) ABDOMINAL PERINEAL, REF DYNJ63371D;   23) ABDOMINAL H

## 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-0646-2025
- **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-0646-2025

## Citation

> AI Analytics. FDA recall Z-0646-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0646-2025. Source: US FDA. Licensed CC0.

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