# FDA recall Z-0523-2026

> **Medline Industries, LP** · Class II · device recall initiated 2025-09-30.

## Product

MEDLINE convenience kits labeled as:    1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G;   2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.

## Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0523-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-30
- **Report date:** 2025-11-26

- **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-0523-2026

## Citation

> AI Analytics. FDA recall Z-0523-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0523-2026. Source: US FDA. Licensed CC0.

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