FDASeptember 30, 2025device

MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.

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

101953274186184019532741861910193489445589401934894455801019532735669940195327356690101953271050204019532710502110195327382803401953273828041019532723926840195327239269

Recall history

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

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