The Recall Desk
HighFDA (Devices)·Z-0521-2026·Announced 2025-11-26

General surgery and knee kits recalled over smoke pencil activation defect

Medline is recalling 20,941 general surgery, laparoscopy and total knee convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall 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 GENERAL LAPAROSCOPY (REF CDS930027W), GENERAL MAJOR CDS (REF CDS980245X), BASIC GENERAL CDS (REF CDS980566F), TOTAL KNEE CDS (REF CDS982823R) and BASIC CDS (REF CDS982936U).

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 20,941 kits, including UDI/DI 10195327601492 for each unit and 40195327601493 for the case, with lots including 24BBC860. 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) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJO
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 24BBC860: UDI/DI 10195327601492 (each)
  • 40195327601493 (case)
  • Lot Numbers: 24BBC860
  • REF 24BBU607: UDI/DI 10193489848434 (each)
  • 40193489848435 (case)
  • Lot Numbers: 24BBU607
  • REF 24CBU583: UDI/DI 10193489848434 (each)
  • Lot Numbers: 24CBU583
  • REF 24EBE546: UDI/DI 10193489848434 (each)
  • Lot Numbers: 24EBE546
  • REF 23GBF733: UDI/DI 10193489445442 (each)
  • 40193489445443 (case)
  • Lot Numbers: 23GBF733
  • REF 24ABG140: UDI/DI 10193489445442 (each)
  • Lot Numbers: 24ABG140
  • REF 24BBN521: UDI/DI 10193489445442 (each)
  • Lot Numbers: 24BBN521
  • REF 24CBR696: UDI/DI 10193489445442 (each)
  • Lot Numbers: 24CBR696
  • REF 24EBK857: UDI/DI 10193489445442 (each)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category