The Recall Desk
HighFDA (Devices)·Z-0522-2026·Announced 2025-11-26

Neuro shunt and laminectomy kits recalled over smoke pencil activation defect

Medline is recalling 1,315 neurosurgery convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

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: Scored 3 under the risk-of-harm criterion: an electrosurgical pencil that can activate without input or stay active is a burn hazard, and no injuries are reported.

Plain-English summary

Medline convenience kits containing SafeAir Smoke Evacuation Pencils are being recalled, including BASIC NEURO PACK (REF CDS780202R), ACDF CDS (REF CDS941061M), NEURO PACK-LF (REF DYNJ0038440C), NEURO VP SHUNT/VAGAL NERVE-RF (REF DYNJ21925S) and NEURO-ORTHO EXTRAS (REF DYNJ44882M).

Stryker Instruments has expanded the scope of its recall of SafeAir Smoke Evacuation Pencils, first initiated in October 2024, adding an additional 47 lots. The initial recall was due to the potential for the product to activate without manual input when plugged into a power source, or to remain active after the buttons are released.

The recall covers 1,315 kits, including UDI/DI 10195327418618 for each unit and 40195327418619 for the case, with lots including 23LMG063. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.

An electrosurgical pencil that activates on its own or stays live is a burn hazard in the operating field. The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Medline's instructions.

The recalled product

Product
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical kit
Hazard
Affected units
1,315

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 CDS780202R
  • UDI/DI 10195327418618 (each) 40195327418619 (case)
  • Lot Numbers: 23LMG063
  • 2) REF CDS941061M
  • UDI/DI 10193489445589 (each) 40193489445580 (case)
  • Lot Numbers: 24ABG356
  • 24CBH117
  • 24DBJ347
  • 3) REF DYNJ0038440C
  • UDI/DI 10195327356699 (each) 40195327356690 (case)
  • Lot Numbers: 23JMC956
  • 23KMF585
  • 24AMB974
  • 4) REF DYNJ21925S
  • UDI/DI 10195327105020 (each) 40195327105021 (case)
  • Lot Numbers: 23EBS176
  • 23GBF899
  • 23HBZ085
  • 5) REF DYNJ44882M
  • UDI/DI 10195327382803 (each) 40195327382804 (case)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 recalled by Medline Industries, LP 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 20 products in this recall →

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