The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0625-2025·Announced 2024-12-11

MEDLINE Surgical Convenience Kits Recalled for Defective Component

Medline Industries is recalling 30,092 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: This is a Class II voluntary precautionary recall with no reported illnesses or injuries. The recall is issued due to a supplier component recall, and no specific hazard is described in the source material. Per the rubric, voluntary precautionary recalls score 2 (Moderate).

Plain-English summary

Medline Industries is recalling 30,092 units of surgical convenience kits distributed nationwide. The recall affects multiple kit types used for vascular, cardiac, pacemaker, and other surgical procedures.

The kits contain SafeAir Smoke Evacuation Pencils manufactured by Stryker, which were subsequently recalled by that company. In response, Medline is performing a secondary recall of all kits containing these pencils across specific lot numbers.

Healthcare facilities and surgical centers that received affected kits should contact Medline Industries for handling instructions. Patients who underwent procedures using these kits should consult with their healthcare provider if they have concerns.

For specific lot numbers and product reference codes affected by this recall, refer to the FDA recall notice Z-0625-2025 and contact Medline Industries directly.

The recalled product

Product
MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4) HEART CDS, REF CDS840387T; 5) OPEN HEART CDS PART A, REF CDS840402AF; 6) OPEN HEART CDS PART A, REF CDS840402AI; 7) HEART…
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits
Hazard
Affected units
30,092

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 CDS840232L
  • UDI/DI 10195327013691 (each) 40195327013692 (case)
  • Lot Numbers: 22FBF374
  • 22FBX255
  • 23EBQ492
  • 23CBW366
  • 23CBW387
  • 23IBS976
  • 2) REF CDS840233I
  • UDI/DI 10195327065270 (each) 40195327065271 (case)
  • Lot Numbers: 22GBJ144
  • 22FBO691
  • 22HBS387
  • 23BBG362
  • 23DBD583
  • 23GBU961
  • 23GBU784
  • 3) REF CDS840261AB
  • UDI/DI 10195327104535 (each) 40195327104536 (case)
  • Lot Numbers: 22FBX514

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 28 recalled by MEDLINE INDUSTRIES, LP - Northfield 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 28 products in this recall →

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