FDA-Device2025-11-26Class IIPROCESSING DEFECT
MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 7) MAJOR ENT MB PACK-LF, REF DYNJ0429404P; 8) THYROID MOFF PACK-LF, REF DYNJ0429430S; 9) NASALPLASTY #61-RF, REF DYNJ27320V; 10) MIDDLE EAR PACK, REF DYNJ55235C; 11) HEAD AND NECK, REF D
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
3078 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 7) MAJOR ENT MB PACK-LF, REF DYNJ0429404P; 8) THYROID MOFF PACK-LF, REF DYNJ0429430S; 9) NASALPLASTY #61-RF, REF DYNJ27320V; 10) MIDDLE EAR PACK, REF DYNJ55235C; 11) HEAD AND NECK, REF DYNJ64235B; 12) NECK PACK SRM-LF, REF DYNJ65020C; 13) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 14) ENT HEAD NECK PACK, REF DYNJ68211B; 15) OSC ENT HEAD PACK, REF DYNJ68957B; 16) EAR UM-LF, REF DYNJ902331D; 17) HEAD&NECK, REF DYNJ906655G; 18) ENT-LF, REF DYNJ907577; 19) MAJOR HEAD AND NECK PPS, REF DYNJ9425991Q; 20) MINOR ENT # 56653-LF, REF DYNJVB91072A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2026More 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.