The Recall Desk
HighFDA (Devices)·Z-0527-2026·Announced 2025-11-26

Gynecology surgery kits recalled over smoke pencils that may activate

Medline is recalling 570 gynecology laparotomy, lithotomy and hysterectomy 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 GYN LAPAROTOMY HARPER PACK-LF (REF DYNJ0160684F), MAJOR LITHOTOMY PACK-LF (REF DYNJ0425778O), MINOR VAGINAL #76-RF (REF DYNJ27434R) and ABDOMINAL HYST PACK (REF DYNJ44848M).

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 570 kits, including UDI/DI 10195327304287 for each unit and 40195327304288 for the case, with lots 23DDC245 and 23GDC219. 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 LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINA
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)

  • 1) REF DYNJ0160684F: UDI/DI 10195327304287 (each) 40195327304288 (case)
  • Lot Numbers: 23DDC245
  • 23GDC219
  • 2) REF DYNJ0425778O: UDI/DI 10198459082290 (each) 40198459082291 (case)
  • Lot Numbers: 24LMF192
  • 3) REF DYNJ27434R: UDI/DI 10195327107727 (each) 40195327107728 (case)
  • Lot Numbers: 24BBR389
  • 24CBH709
  • 4) REF DYNJ44848M: UDI/DI 10195327415952 (each) 40195327415953 (case)
  • Lot Numbers: 23EDB911
  • 23FDC315
  • 23HDA180
  • 5) REF DYNJ44863Q: UDI/DI 10195327298227 (each) 40195327298228 (case)
  • Lot Numbers: 23FDB122
  • 23GDC100
  • 6) REF DYNJ44900P: UDI/DI 10195327298548 (each) 40195327298549 (case)
  • Lot Numbers: 23DDB824
  • 23EDA215
  • 23FDB287
  • 7) REF DYNJ50047G: UDI/DI 10195327107734 (each) 40195327107735 (case)

Distribution

Distributed nationwide across the United States.

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