PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 26, 2025 Initiated: September 30, 2025 #Z-0528-2026

Product Description

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

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.

Details

Recalling Firm
Medline Industries, LP
Units Affected
18 units
Distribution
US Nationwide distribution.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F. Recalled by Medline Industries, LP. Units affected: 18 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 26, 2025. Severity: Moderate. Recall number: Z-0528-2026.