The Recall Desk
HighFDA (Devices)·Z-0630-2025·Announced 2024-12-11

Medline Surgical Kits Recalled Due to Defective Smoke Evacuation Component

Medline is recalling 167,074 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils previously recalled by manufacturer Stryker for use in various surgical procedures.

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: FDA Class II classification for a surgical device with a recalled component. The recall classification and component-level issue indicate potential risk to surgical patients.

Plain-English summary

Medline Industries, LP is recalling 167,074 surgical convenience kits nationwide because they contain SafeAir Smoke Evacuation Pencils that were previously recalled by their manufacturer, Stryker. The affected kits are designated for use in various surgical procedures, including abdominal laparoscopy, laparotomy, and general surgery operations.

The affected kits were distributed nationwide to hospitals and surgical facilities. Healthcare providers using these products should discontinue use immediately and contact Medline Industries for guidance on replacement or return of the affected kits. The FDA has assigned recall number Z-0630-2025 to this recall.

The recalled product

Product
MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits
Hazard
  • defective-component

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 CDS760057J
  • UDI/DI 10195327008963 (each) 40195327008964 (case)
  • Lot Numbers: 22FBX954
  • 22FBE976
  • 2) REF CDS760057K
  • UDI/DI 10195327274368 (each) 40195327274369 (case)
  • Lot Numbers: 23ABU244
  • 22LBC409
  • 23GBN928
  • 23CBO552
  • 23EBA183
  • 23JBH987
  • 3) REF CDS760057L
  • UDI/DI 10195327533373 (each) 40195327533374 (case)
  • Lot Numbers: 23KBL294
  • 4) REF CDS860015W
  • UDI/DI 10195327349509 (each) 40195327349500 (case)
  • Lot Numbers: 23FBP597
  • 5) REF CDS860016P
  • UDI/DI 10193489848007 (each) 40193489848008 (case)

Distribution

Distributed nationwide across the United States.

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