Medical device recalls Moderate risk

Medline Industries, LP recalls MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F

Recall date
September 30, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0528-2026
FDA classification
Class II
Brand / firm
Medline Industries, LP
Sold / distributed
US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F

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