The Recall Desk
HighFDA (Devices)·Z-0519-2026·Announced 2025-11-26

Breast and plastics packs recalled over smoke pencils that may activate

Medline is recalling 4,214 breast, abdominoplasty and plastics 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 ACH PLASTICS BREAST-LF (REF CDS983639K), BREAST ABD (REF CDS984267J), PLASTIC PACK (REF DYNJ00264M) and two breast abdominoplasty packs.

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 4,214 kits, including UDI/DI 10195327351533 for each unit and 40195327351534 for the case, with lot 23FBP157. 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) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M; 6) AUGMENTATION #
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical kit
Hazard
Affected units
4,214

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 CDS983639K: UDI/DI 10195327351533 (each)
  • 40195327351534 (case)
  • Lot Number 23FBP157
  • Lot Number 23GBM569
  • REF CDS984267J: UDI/DI 10193489288872 (each)
  • 40193489288873 (case)
  • Lot Number 23LBN523
  • Lot Number 24BBA266
  • Lot Number 24CBS676
  • Lot Number 24EBM454
  • REF DYNJ00264M: UDI/DI 10195327418717 (each)
  • 40195327418718 (case)
  • Lot Number 23HMA639
  • Lot Number 23HMF507
  • REF DYNJ0428947L: UDI/DI 10195327329136 (each)
  • 40195327329137 (case)
  • Lot Number 23GMI327
  • Lot Number 23JMC006
  • Lot Number 23LMA065
  • Lot Number 23LMC367

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 →

Related recalls

Same manufacturer · Medline Industries, LP

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Same hazard · unintended activation

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