The Recall Desk
HighFDA (Devices)·Z-0530-2026·Announced 2025-11-26

Neuro and joint kits recalled over smoke pencils that may activate

Medline is recalling 40,151 neurosurgery, back and joint 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 NEURO CRANIOTOMY CDS #36-RF (REF CDS780119V), BASIC BACK CDS (REF CDS780147N), INSTRUMENTED BACK CDS (REF CDS780148R), NEURO-LAMI CDS (REF CDS780208I) and TOTAL HIP (REF CDS920027Y).

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 40,151 kits, including UDI/DI 10195327114916 for each unit and 40195327114917 for the case, with lots including 23GBQ904. 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) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTA
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical kit
Hazard
  • unintended-activation
  • electrosurgical
  • burn-risk
  • recall-expansion

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)

  • REF CDS780119V: UDI/DI 10195327114916 (each) 40195327114917 (case)
  • Lot Numbers: 23GBQ904
  • Lot Numbers: 23JBS979
  • REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case)
  • Lot Numbers: 23LBD720
  • Lot Numbers: 24BBK043
  • Lot Numbers: 24CBA347
  • Lot Numbers: 24EBM283
  • Lot Numbers: 24GBB624
  • REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case)
  • Lot Numbers: 23GBS348
  • Lot Numbers: 23HBJ325
  • Lot Numbers: 24ABK205
  • Lot Numbers: 24ABW098
  • Lot Numbers: 24BBN591
  • Lot Numbers: 24CBS634
  • REF CDS780208I: UDI/DI 10195327525231 (each) 40195327525232 (case)
  • Lot Numbers: 23JBU709
  • REF CDS920027Y: UDI/DI 10195327298531 (each) 40195327298532 (case)
  • Lot Numbers: 23LBF304

Distribution

Distributed nationwide across the United States.

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