FDASeptember 30, 2025device

MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTAL KNEE REPLACEMENT CDS, REF CDS9...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

medline industries lpmedlinemedline industries

UPCs

101953271149164019532711491710195327268770401953272687711019532726878740195327268788101953275252314019532752523210195327298531401953272985321019532730084540195327300846

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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