The Recall Desk
ModerateFDA (Devices)·Z-0633-2025·Announced 2024-12-11

MEDLINE Recalls Medical Convenience Kits Containing Recalled SafeAir Component

MEDLINE is recalling approximately 25,877 medical convenience kits distributed nationwide that contain SafeAir Smoke Evacuation Pencil components previously recalled by Stryker.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II device recall with no reported illnesses or injuries. The recall is precautionary in nature—Medline is removing kits containing a component previously recalled by Stryker, but no specific hazard or adverse events are described in the source material.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling approximately 25,877 medical convenience kits distributed nationwide. The kits were manufactured using SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.

The recall affects multiple kit types used in plastic surgery, breast reconstruction, and other surgical procedures. Affected products include items referenced as MAMMOPLASTY-LF, PLASTICS FREE FLAP, PLASTIC TORSO-LF, and numerous other surgical procedure kits with specific reference numbers and lot numbers identified by the FDA.

Healthcare facilities and surgical centers in possession of these kits should cease use immediately and verify their inventory against the affected lot numbers and product reference codes listed in the FDA recall notice. Contact MEDLINE INDUSTRIES, LP at Northfield for information on product replacement or proper disposition.

The recalled product

Product
MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTICS FREE FLAP, REF CDS983493M; 4) PLASTIC TORSO-LF, REF CDS983496L; 5) PLASTIC TORSO-LF, REF CDS983496M; 6) PLASTIC HEAD AND NECK-LF, REF CDS983498N; 7) ACH
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
  • component-defect

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 CDS983478L
  • UDI/DI 10195327497286 (each) 40195327497287 (case)
  • Lot Numbers: 23JDA999
  • 23KDB756
  • 24ADA957
  • 24DDA553
  • 2) REF CDS983478M
  • UDI/DI 10198459000065 (each) 40198459000066 (case)
  • Lot Numbers: 24EDB504
  • 3) REF CDS983493M
  • UDI/DI 10195327497415 (each) 40195327497416 (case)
  • Lot Numbers: 23LDA144
  • 24ADA328
  • 4) REF CDS983496L
  • UDI/DI 10195327497408 (each) 40195327497409 (case)
  • Lot Numbers: 23KDC085
  • 24ADB601
  • 5) REF CDS983496M
  • UDI/DI 10198459000201 (each) 40198459000202 (case)
  • Lot Numbers: 24EDA817

Distribution

Distributed nationwide across the United States.

Related recalls

Same category