The Recall Desk
HighFDA (Devices)·Z-0629-2025·Announced 2024-12-11

MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Pencil Component

MEDLINE is recalling 102 varieties of surgical convenience kits containing SafeAir Smoke Evacuation Pencils that have been recalled by manufacturer Stryker. The nationwide recall affects 24,754 units.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II device recall involving surgical instruments used in sensitive head and neck procedures. Although no injuries or illnesses are reported in the source material, the recall indicates a risk-of-harm situation where a component (SafeAir Smoke Evacuation Pencil) was recalled by its manufacturer.

Plain-English summary

MEDLINE Industries is recalling 102 variations of surgical convenience kits used in head, neck, ear, and throat procedures. These convenience kits contain SafeAir Smoke Evacuation Pencils that have been separately recalled by Stryker, the device manufacturer.

The recall affects 24,754 units distributed nationwide. Affected kits include 102 product references with lot numbers manufactured between 2022 and 2024.

Healthcare facilities, surgical centers, and hospitals should immediately discontinue use of the recalled convenience kits. Facilities should verify their inventory against the provided reference numbers and lot numbers to identify affected products and contact MEDLINE for return or replacement instructions.

The recalled product

Product
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A,
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Instrument Kit / ENT
Hazard
Affected units
24,754

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) REF CDS983184I
  • UDI/DI 10195327178352 (each) 40195327178353 (case)
  • Lot Numbers: 22LBB795
  • 23FBJ754
  • 23BBH106
  • 23CBT619
  • 23HBY087
  • 23HBP974
  • 23KBI669
  • 23LBD939
  • 23KBM394
  • 2) REF CDS983466L
  • UDI/DI 10195327497217 (each) 40195327497218 (case)
  • Lot Numbers: 23JDB850
  • 23IDB539
  • 23KDB596
  • 24DDB278
  • 24DDA871
  • 24BDA878
  • 24ADA819

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 28 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 28 products in this recall →

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