FDA-Device2025-11-26Class IIPROCESSING DEFECT
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
12 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0518-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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