The Recall Desk
HighFDA (Devices)·Z-0640-2025·Announced 2024-12-11

MEDLINE convenience kits recalled due to defective component

Medline is recalling multiple lots of its convenience kits because they contain a component (SafeAir Smoke Evacuation Pencil) that was previously recalled by Stryker. The affected kits are distributed nationwide.

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: This is a Class II medical device recall of surgical kits used in neurological procedures. The kits contain a component that was previously recalled by Stryker, indicating a potential safety issue. Although the specific hazard is not detailed in the recall notice and no illnesses or injuries have been reported, these kits are used in high-risk surgical procedures, qualifying as risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling multiple models and lot numbers of convenience kits used in neurological and spinal procedures. The kits are manufactured with a component known as the SafeAir Smoke Evacuation Pencil, which was previously recalled by Stryker.

The recall affects 12,847 units distributed nationwide. Affected kits include multiple product lines such as Basic Neuro Pack, ACDF CDS, Neuro Kit, VP Shunt kits, and specialized kits for neurosurgery, spine procedures, and other surgical applications. Specific lot numbers for each product model are listed by Medline and are available through the FDA recall notice.

Healthcare facilities that have received affected kits should stop use of the recalled component and contact Medline or Stryker for instructions on replacement or remediation. The complete list of affected product reference numbers and lot numbers is available in the FDA recall announcement.

The recalled product

Product
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, R
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits / Neurosurgical
Hazard
Affected units
12,847

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)

  • 84OJG 1) REF CDS780202P
  • UDI/DI 10195327096458 (each) 40195327096459 (case)
  • Lot Numbers: 22IMA512
  • 22IMA513
  • 22FMD852
  • 22GME200
  • 22FMH471
  • 22LMA065
  • 2) REF CDS780202Q
  • UDI/DI 10195327265304 (each) 40195327265305 (case)
  • Lot Numbers: 22LMA225
  • 23EME852
  • 23DME052
  • 3) REF CDS780202R
  • UDI/DI 10195327418618 (each) 40195327418619 (case)
  • Lot Numbers: 23FMI343
  • 4) REF CDS941061M
  • UDI/DI 10193489445589 (each) 40193489445580 (case)
  • Lot Numbers: 22EBB662
  • 22JBR840

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 →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · component defect

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