The Recall Desk
HighFDA (Devices)·Z-0626-2025·Announced 2024-12-11

Medline recalls surgical convenience kits with defective smoke evacuation component

Medline is recalling five types of medical convenience kits because they contain the SafeAir Smoke Evacuation Pencil, which Stryker subsequently recalled.

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: Class II medical device recall without reported illnesses or injuries. The product contains a defective surgical component, constituting a risk-of-harm product without documented injury, meeting the criteria for High severity.

Plain-English summary

Medline Industries is recalling five models of medical convenience kits that were manufactured using certain lots of the SafeAir Smoke Evacuation Pencil. The affected kits are CVL PACK (REF DYNJ00281O), VASCULAR ACCESS PACK-LF (REF DYNJ0101291F), MAJOR VASCULAR PACK-LF (REF DYNJ0488546K), PEDS CENTRAL LINE PACK (REF DYNJ84762), and PACK, CENTRAL LINE (REF DYNJ906907C).

Medline is recalling these kits because they were manufactured using certain lots of the SafeAir Smoke Evacuation Pencil, which Stryker subsequently recalled. The specific nature of the defect affecting the SafeAir component is not described in this FDA recall notice.

These convenience kits have been distributed nationwide throughout the United States. Specific lot numbers for each affected product variant are documented in the official FDA recall notice. No illnesses, injuries, or deaths have been reported in connection with this recall.

The recalled product

Product
MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF DYNJ0488546K; 4) PEDS CENTRAL LINE PACK, REF DYNJ84762; 5) PACK,CENTRAL LINE, REF DYNJ906907C
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits
Hazard
  • surgical-tool-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 DYNJ00281O
  • UDI/DI 10193489962963 (each) 40193489962964 (case)
  • Lot Numbers: 22KMA417
  • 22FMD671
  • 2) REF DYNJ0101291F
  • UDI/DI 10195327286644 (each) 40195327286645 (case)
  • Lot Numbers: 23FDA396
  • 23HDA759
  • 23EDB388
  • 23LDB909
  • 3) REF DYNJ0488546K
  • UDI/DI 10195327505097 (each) 40195327505098 (case)
  • Lot Numbers: 23IBP983
  • 4) REF DYNJ84762
  • UDI/DI 10195327413088 (each) 40195327413089 (case)
  • Lot Numbers: 23IMA327
  • 23IMA727
  • 5) REF DYNJ906907C
  • UDI/DI 10195327376819 (each) 40195327376810 (case)
  • Lot Numbers: 23DBM940

Distribution

Distributed nationwide across the United States.

Related recalls

Same category