The Recall Desk
HighFDA (Devices)·Z-0515-2026·Announced 2025-11-26

Breast biopsy packs recalled over smoke pencils that may activate

Medline is recalling 301 breast biopsy and mastectomy convenience packs 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 BREAST BIOPSY PACK-LF (REF DYNJ0160598C), BIOPSY BREAST PACK (REF DYNJ65361A) and BREAST BIOPSY/MASTECTOMY (REF DYNJ908839A).

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 301 units, including UDI/DI 10195327304270 for each unit and 40195327304271 for the case, with lots 23DDC250 and 23GDA351. 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) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.
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 (16)

  • 1) REF DYNJ0160598C: UDI/DI 10195327304270 (each)
  • 40195327304271 (case)
  • Lot Numbers: 23DDC250
  • 23GDA351
  • 2) REF DYNJ65361A: UDI/DI 10195327415051 (each)
  • 40195327415052 (case)
  • Lot Numbers: 24BMC296
  • 3) REF DYNJ908839A: UDI/DI 10195327431822 (each)
  • 40195327431823 (case)
  • Lot Numbers: 23GBL904
  • 23GBU981
  • 23HBF736
  • 23HBO368
  • 24BBP268
  • 24CBO698
  • 24EBS782.

Distribution

Distributed nationwide across the United States.

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