Class II U.S. Food and Drug Administration

Medline convenience kits labeled as: 1) Basic Neuro Pack, REF CDS780202R recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)

Recall published 11 months ago

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

The hazard: Fire or burn hazard

This product can overheat or catch fire, which is why the instruction is to unplug and stop using it rather than to keep an eye on it.

What the notice says: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

Why it matters: The product can overheat, ignite or cause a burn. Where lithium batteries are involved the failure is fast and very hot, and water does not put it out quickly.

Symptoms and when to call a doctor

Treat a burn by cooling it under running water for about 20 minutes — not with ice, butter or ointment — and cover it loosely with a clean non-fluffy cloth. Get medical help for burns that are larger than the person’s palm, that are deep or white or charred, that involve the face, hands, feet or genitals, or any burn to a baby or young child. If someone has inhaled smoke and is coughing, hoarse or short of breath, call 911.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0522-2026
Published
November 26, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
1315 kits
Distribution
Nationwide
Made in
United States
Lot / code info
1) REF CDS780202R, UDI/DI 10195327418618 (each) 40195327418619 (case), Lot Numbers: 23LMG063; 2) REF CDS941061M, UDI/DI 10193489445589 (each) 40193489445580 (case), Lot Numbers: 24ABG356, 24CBH117, 24DBJ347; 3) REF DYNJ0038440C, UDI/DI 10195327356699 (each) 40195327356690 (case), Lot Numbers: 23JMC956, 23KMF585, 24AMB974; 4) REF DYNJ21925S, UDI/DI 10195327105020 (each) 40195327105021 (case), Lot Numbers: 23EBS176, 23GBF899, 23HBZ085; 5) REF DYNJ44882M, UDI/DI 10195327382803 (each) 40195327382804 (case), Lot Numbers: 23FDA522, 23GDB903; 6) REF DYNJ903870F, UDI/DI 10195327239268 (each) 40195327239269 (case), Lot Numbers: 23IBD913, 23IBD914, 23JBL889, 24ABE596, 24BBL042, 24CBH196, 24DBU825.
UPC codes
10195327418618, 40195327418619, 10193489445589, 40193489445580, 10195327356699, 40195327356690, 10195327105020, 40195327105021, 10195327382803, 40195327382804, 10195327239268, 40195327239269

Products covered by this recall

MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.

Check your product

The notice names 45 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10195327418618
  • 40195327418619
  • 10193489445589
  • 40193489445580
  • 10195327356699
  • 40195327356690
  • 10195327105020
  • 40195327105021
  • 10195327382803
  • 40195327382804
  • 10195327239268
  • 40195327239269

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 23LMG063
  • 24ABG356
  • 24CBH117
  • 24DBJ347
  • 23JMC956
  • 23KMF585
  • 24AMB974
  • 23EBS176
  • 23GBF899
  • 23HBZ085
  • 23FDA522
  • 23GDB903
  • 23IBD913
  • 23IBD914
  • 23JBL889
  • 24ABE596
  • 24BBL042
  • 24CBH196
  • 24DBU825

Model or item number

On the rating label, the box or the instruction sheet.

  • CDS780202R
  • CDS941061M
  • DYNJ0038440C
  • DYNJ21925S
  • DYNJ44882M
  • DYNJ903870F. — 1
  • UDI
  • DI 10195327418618
  • DI 10193489445589
  • DI 10195327356699
  • DI 10195327105020
  • DI 10195327382803
  • DYNJ903870F
  • DI 10195327239268

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fire

Medline Industries, LP — This product can overheat or catch fire, which is why the instruction is to unplug and stop using it rather than to keep an eye on it.

  1. Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.
  2. Move it off anything that burns — a bed, a sofa, a carpet, a pile of paper — and away from exits.
  3. Do not leave it charging overnight or while the house is empty while you wait for the remedy.
  4. If it has already overheated, scorched or swelled, do not keep using it and do not try to repair it.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • If the company stops responding, escalate to the CPSC. Firms under a recall order have reporting duties to the agency.
  • Have the model number, the date code and your photos ready. Many companies issue store credit by default — ask for cash or a card reversal if you would rather have it.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10195327418618, 40195327418619, 10193489445589; lot code 23LMG063, 24ABG356, 24CBH117; model number CDS780202R, CDS941061M, DYNJ0038440C. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.

Can I get my money back?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

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