The Recall Desk
HighFDA (Devices)·Z-0524-2026·Announced 2025-11-26

Gynecology and robotic kits recalled over smoke pencils that may self activate

Medline is recalling 2,844 gynecology laparoscopy and robotic 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 GYN LAPAROSCOPY CDS #34-RF (REF CDS920099S), GYN LAPAROSCOPY CDS-LF (REF CDS983764J), ROBOTIC (REFs CDS984262N and CDS984262P) and ROBOTIC UROLOGY-RF (REF DYNJ38844N).

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 2,844 kits, including UDI/DI 10195327140656 for each unit and 40195327140657 for the case, with lots including 23LBV707. 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) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical kit
Hazard
Affected units
2,844

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 CDS920099S: UDI/DI 10195327140656 (each) 40195327140657 (case)
  • Lot Numbers: 23LBV707
  • Lot Numbers: 24CBD429
  • Lot Numbers: 24CBD498
  • Lot Numbers: 24DBK836
  • Lot Numbers: 24HBE577
  • REF CDS983764J: UDI/DI 10195327451219 (each) 40195327451210 (case)
  • Lot Numbers: 23HBO463
  • Lot Numbers: 23JBF467
  • REF CDS984262N: UDI/DI 10195327241735 (each) 40195327241736 (case)
  • Lot Numbers: 24ABP835
  • REF CDS984262P: UDI/DI 10195327647704 (each) 40195327647705 (case)
  • Lot Numbers: 24CBK422
  • REF DYNJ38844N: UDI/DI 10195327243166 (each) 40195327243167 (case)
  • Lot Numbers: 23GBT512
  • Lot Numbers: 23HBI619
  • Lot Numbers: 23LBN095
  • Lot Numbers: 24BBR322
  • Lot Numbers: 24DBA027
  • Lot Numbers: 24DBT103

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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