The Recall Desk
HighFDA (Devices)·Z-0513-2026·Announced 2025-11-26

Vascular and open heart kits recalled over smoke pencils that may activate

Medline is recalling 5,133 vascular, carotid and open heart 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 AAA #11-RF (REF CDS840261AB), CAROTID ENDARTERECTOMY CDS-LF (REF CDS983637I), PERIPHERAL VASCULAR CDS (REF CDS983723J), ACH OPEN HEART (REF CDS983773J) and VASCULAR (REF CDS984255K).

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 5,133 kits, including UDI/DI 10195327104535 for each unit and 40195327104536 for the case, with lots 23FBF165 and 23JBM632. 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 AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF,
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical kit
Hazard
Affected units
5,133

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) CDS840261AB: UDI/DI 10195327104535 (each)
  • 40195327104536 (case)
  • Lot Numbers: 23FBF165
  • 23JBM632. 2) CDS983637I: UDI/DI 10195327228125 (each)
  • 40195327228126 (case)
  • Lot Numbers: 23GBU191. 3) CDS983723J: UDI/DI 10195327327828 (each)
  • 40195327327829 (case)
  • Lot Numbers: 23FBA013
  • 23FBH486
  • 23GBE805. 4) CDS983773J: UDI/DI 10195327233617 (each)
  • 40195327233618 (case)
  • Lot Numbers: 23GBT133
  • 23HBH924
  • 23HBL135
  • 23HBV936. 5) CDS984255K: UDI/DI 10193489288605 (each)
  • 40193489288606 (case)
  • Lot Numbers: 23KBU348
  • 24ABB883
  • 24ABS338. 6) DYNJ0161262C: UDI/DI 10195327357283 (each)
  • 40195327357284 (case)

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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Same hazard · unintended activation

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