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Recall Observatory FDA recall evidence

Device product

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

Z-0528-2026

September 30, 2025

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 97846
Status
Ongoing
Classification
Class II
Quantity
18 units
Official record key
device-enforcement:Z-0528-2026

Official wording

Reason: 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.

Code information: UDI/DI 10195327454227 (each) 40195327454228 (case), Lot Numbers: 23HDA742

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.