Class II U.S. Food and Drug Administration

Medline convenience kits labeled as: 1) Head AND Neck, REF CDS984259O 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

The hazard here is thermal: the product can get hot enough to ignite what is around it, or to burn whoever is holding 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-0516-2026
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
3078 kits
Distribution
Nationwide
Made in
United States
Lot / code info
1) REF CDS984259O: UDI/DI 10195327297817 (each), 40195327297818 (case), Lot Numbers: 23FBR754, 23GBH766, 24ABP608, 24BBN514; 2) REF CDS984259P: UDI/DI 10195327647827 (each), 40195327647828 (case), Lot Numbers: 24DBQ755; 3) REF DYNJ0160700F: UDI/DI 10195327304294 (each), 40195327304295 (case), Lot Numbers: 23FDA156, 23GDA649; 4) REF DYNJ0161710I: UDI/DI 10195327375003 (each), 40195327375004 (case), Lot Numbers: 23EDB639, 23FDA196, 23GDA674; 5) REF DYNJ0161795F: UDI/DI 10195327375010 (each), 40195327375011 (case), Lot Numbers: 23FDA246, 23HDA365; 6) REF DYNJ0429404O: UDI/DI 10195327050092 (each), 40195327050093 (case), Lot Numbers: 23GMI073, 23JMC414, 23LMA073; 7) REF DYNJ0429404P: UDI/DI 10195327587581 (each), 40195327587582 (case), Lot Numbers: 23LMH745, 24BME178, 24DMF230; 8) REF DYNJ0429430S: UDI/DI 10195327689841 (each), 40195327689842 (case), Lot Numbers: 24LME516; 9) REF DYNJ27320V: UDI/DI 10195327104719 (each), 40195327104710 (case), Lot Numbers: 23GBT502, 24ABD023, 24ABX584, 24DBA020, 24DBU467, 24FBD739; 10) REF DYNJ55235C: UDI/DI 10195327412081 (each), 40195327412082 (case), Lot Numbers: 23GBN444, 23IBU467; 11) REF DYNJ64235B: UDI/DI 10193489382662 (each), 40193489382663 (case), Lot Numbers: 23FMB928; 12) REF DYNJ65020C: UDI/DI 10195327528218 (each), 40195327528219 (case), Lot Numbers: 23JMD840, 23LME135, 24FMH184; 13) REF DYNJ67754B: UDI/DI 10195327227982 (each), 40195327227983 (case), Lot Numbers: 23EBK256, 23HBM886, 23IBP461, 23JBR528; 14) REF DYNJ68211B: UDI/DI 10195327352493 (each), 40195327352494 (case), Lot Numbers: 23HMC691; 15) REF DYNJ68957B: UDI/DI 10195327512033 (each), 40195327512034 (case), Lot Numbers: 23JMD230, 24AMB618; 16) REF DYNJ902331D: UDI/DI 10195327698089 (each), 40195327698080 (case), Lot Numbers: 24EBC946, 24EBV522; 17) REF DYNJ906655G: UDI/DI 10195327301835 (each), 40195327301836 (case), Lot Numbers: 24ADB523; 18) REF DYNJ907577: UDI/DI 10193489437713 (each), 40193489437714 (case), Lot Numbers: 23GBB195, 23GBN735; 19) REF DYNJ9425991Q: UDI/DI 10195327587604 (each), 40195327587605 (case), Lot Numbers: 24ALB133; 20) REF DYNJVB91072A: UDI/DI 10195327466428 (each), 40195327466429 (case), Lot Numbers: 23HLB079, 23ILA192, 24ALA650.
UPC codes
10195327297817, 40195327297818, 10195327647827, 40195327647828, 10195327304294, 40195327304295, 10195327375003, 40195327375004, 10195327375010, 40195327375011, 10195327050092, 40195327050093, 10195327587581, 40195327587582, 10195327689841, 40195327689842, 10195327104719, 40195327104710, 10195327412081, 40195327412082

Products covered by this recall

MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 7) MAJOR ENT MB PACK-LF, REF DYNJ0429404P; 8) THYROID MOFF PACK-LF, REF DYNJ0429430S; 9) NASALPLASTY #61-RF, REF DYNJ27320V; 10) MIDDLE EAR PACK, REF DYNJ55235C; 11) HEAD AND NECK, REF DYNJ64235B; 12) NECK PACK SRM-LF, REF DYNJ65020C; 13) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 14) ENT HEAD NECK PACK, REF DYNJ68211B; 15) OSC ENT HEAD PACK, REF DYNJ68957B; 16) EAR UM-LF, REF DYNJ902331D; 17) HEAD&NECK, REF DYNJ906655G; 18) ENT-LF, REF DYNJ907577; 19) MAJOR HEAD AND NECK PPS, REF DYNJ9425991Q; 20) MINOR ENT # 56653-LF, REF DYNJVB91072A.

Check your product

The notice names 60 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.

  • 10195327297817
  • 40195327297818
  • 10195327647827
  • 40195327647828
  • 10195327304294
  • 40195327304295
  • 10195327375003
  • 40195327375004
  • 10195327375010
  • 40195327375011
  • 10195327050092
  • 40195327050093
  • 10195327587581
  • 40195327587582
  • 10195327689841
  • 40195327689842
  • 10195327104719
  • 40195327104710
  • 10195327412081
  • 40195327412082

Lot or batch code

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

  • 23FBR754
  • 23GBH766
  • 24ABP608
  • 24BBN514
  • 24DBQ755
  • 23FDA156
  • 23GDA649
  • 23EDB639
  • 23FDA196
  • 23GDA674
  • 23FDA246
  • 23HDA365
  • 23GMI073
  • 23JMC414
  • 23LMA073
  • 23LMH745
  • 24BME178
  • 24DMF230
  • 24LME516
  • 23GBT502

Model or item number

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

  • CDS984259O
  • CDS984259P
  • DYNJ0160700F
  • DYNJ0161710I
  • DYNJ0161795F
  • DYNJ0429404O
  • DYNJ0429404P
  • DYNJ0429430S
  • DYNJ27320V
  • DYNJ55235C
  • DYNJ64235B
  • DYNJ65020C
  • DYNJ67754B
  • DYNJ68211B
  • DYNJ68957B
  • DYNJ902331D
  • DYNJ906655G
  • DYNJ907577
  • DYNJ9425991Q
  • DYNJVB91072A. — 1

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 — The hazard here is thermal: the product can get hot enough to ignite what is around it, or to burn whoever is holding it.

  1. Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.
  2. If it has already overheated, scorched or swelled, do not keep using it and do not try to repair it.
  3. Check that your smoke alarms work while you are thinking about it, and follow the remedy on this page.
  4. Move it off anything that burns — a bed, a sofa, a carpet, a pile of paper — and away from exits.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.

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 10195327297817, 40195327297818, 10195327647827; lot code 23FBR754, 23GBH766, 24ABP608; model number CDS984259O, CDS984259P, DYNJ0160700F. 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?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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