The Recall Desk
ModerateFDA (Devices)·Z-0624-2025·Announced 2024-12-11

Medline Surgical Kits Recalled for SafeAir Smoke Evacuation Pencils

Medline is recalling 1,271 surgical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. The affected kits were distributed nationwide, and healthcare facilities should discontinue use.

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 recall initiated as a precautionary measure due to a supplier component that was previously recalled by Stryker. No illnesses or injuries related to these kits have been reported, making this a secondary/precautionary recall without demonstrated patient harm.

Plain-English summary

Medline Industries is recalling five models of surgical convenience kits that contain SafeAir Smoke Evacuation Pencils. The recalled products are ANGIO PACK #2, CV MINOR CATH LAB PACK, PLASTIC PACK, GENDER AFFIRMING SURGERY KIT, and ST CHARLES PORT. Approximately 1,271 units were distributed nationwide.

The SafeAir Smoke Evacuation Pencils used in these kits were previously recalled by Stryker. Medline has initiated this recall of the affected kits in response to the component recall.

Healthcare facilities that received these kits should identify affected units by referencing the specific lot numbers provided in the FDA recall notice. Affected kits should be removed from service, and facilities should contact Medline for return instructions and replacement options.

The recalled product

Product
MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5) ST CHARLES PORT, REFDYNJ909591
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kit
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 DYNJ39185D
  • UDI/DI 10195327157166 (each) 40195327157167 (case)
  • Lot Numbers: 22GBA088
  • 22FBS934
  • 22HBA086
  • 2) REF DYNJ44997J
  • UDI/DI 1019532738093 (each) 40195327380930 (case)
  • Lot Numbers: 23GBU050
  • 23KBI422
  • 23JBL004
  • 23IBB532
  • 23LBK392
  • 24BBA287
  • 24CBM430
  • 3) REF DYNJ58409C
  • UDI/DI 10193489957242 (each) 40193489957243 (case)
  • Lot Numbers: 22GBT985
  • 22LBD309
  • 23JBP407
  • 4) REF DYNJ66252A

Distribution

Distributed nationwide across the United States.

Related recalls

Same category