FDA-Device2025-11-26Class IIPROCESSING DEFECT
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
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.
Who it affects
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: CATH LAB PACEMAKER PACK, REF DYNJ59818A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0512-2026More Medline recalls
- FDA-PR2026-08-05Medline Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits recalled for connector overheating risk
- FDA-Device2026-07-29Medline surgical convenience kits recalled for quality issues in anesthetic component
- FDA-Device2026-07-29Medline NEURO PACK medical kits recalled for Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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