← FDA ENFORCEMENT
Z-0525-2026Class II

Medline Industries, LP

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2025-11-26
Distribution
US Nationwide distribution.
Firm state
IL
Product quantity
120 kits
Initiated by
Voluntary: Firm initiated
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.

Product description

MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O

Code / lot info

UDI/DI: 10195327412067 (each) 40195327412068 (case), Lot Numbers: 23GMC962

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →