Class II U.S. Food and Drug Administration

Medline convenience kits labeled as: 1) C-Section OR 30 CDS 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-0526-2026
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
11032 kits
Distribution
Nationwide
Made in
United States
Lot / code info
REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 23JBR313; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 23KBB240; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 24DBA895; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 24EBI651; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23FBP399; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23HBP624; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23IBE037; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23JBC747; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 23LBM204; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24ABL069; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24CBM113; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24FBE246; REF DYNJ02577D, UDI/DI: 10193489958003 (each) 40193489958004 (case), Lot Numbers: 23EDA073; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23GBP147; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23HBD395; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23HBP685; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 24BBV536; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 24EBF239; REF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 23HMD981; REF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 23KBF163; REF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 24BBH765; REF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 24BBT798; REF DYNJ0551409P, UDI/DI: 10195327561871 (each) 40195327561872 (case), Lot Numbers: 24BBC833; REF DYNJ07836R, UDI/DI: 10195327349431 (each) 40195327349432 (case), Lot Numbers: 24BBH764; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 23LBC980; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24ABQ944; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24ABR003; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24ABV987; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24BBG949; REF DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case), Lot Numbers: 23GMF903; REF DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case), Lot Numbers: 23HMF589; REF DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case), Lot Numbers: 23JMB497; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23EBO244; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23FBR011; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23HBD673; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23HBH801; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23IBP528; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23DMF816; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23DMI790; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23EMG135; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23FMI968; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23GMI116; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23HMA195; REF DYNJ38063D, UDI/DI:…
UPC codes
10195327209797, 40195327209798, 10195327139629, 40195327139620, 10193489645606, 40193489645607, 10193489958003, 40193489958004, 10195327206246, 40195327206247, 10889942826582, 40889942826583, 10195327561871, 40195327561872, 10195327349431, 40195327349432, 10195327496609, 40195327496600, 10195327351373, 40195327351374

Products covered by this recall

MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECTION PACK-LF, REF DYNJ0551409P; 8) C-SECTION PACK-LF, REF DYNJ07836R; 9) C-SECTION, REF DYNJ14103C; 10) C-SECTION PACK, REF DYNJ19417R; 11) C-SECTION PACK-LF, REF DYNJ33059B; 12) C-SECTION PACK SC-LF, REF DYNJ38063D; 13) C-SECTION PACK SC-LF, REF DYNJ38700G; 14) C-SECTION PACK-LF, REF DYNJ38845D; 15) C-SECTION PACK-LF, REF DYNJ38845F; 16) C-SECTION PACK, REF DYNJ44679L; 17) C-SECTION DELIVERY PACK-LF, REF DYNJ47808F; 18) C SECTION PACK, REF DYNJ48087I; 19) C-SECTION I, REF DYNJ51354B; 20) C-SECTION SAFETY PACK, REF DYNJ52481B; 21) C-SECTION SMMC, REF DYNJ59457B; 22) C-SECTION PACK, REF DYNJ59825A; 23) PK CUST C-SECTION ST MICH, REF DYNJ60544C; 24) C SECTION PACK, REF DYNJ64377D; 25) C-SECTION PACK, REF DYNJ64505B; 26) C SECTION SHARED, REF DYNJ64775C; 27) LDRP-C SECTION PACK-LF, REF DYNJ64834A; 28) LDRP-C SECTION PACK-LF, REF DYNJ64834B; 29) C-SECTION PACK-LF, REF DYNJ65031D; 30) C SECTION PK, REF DYNJ65403A; 31) C SECTION PACK-LF, REF DYNJ65765A; 32) C-SECTION PACK-LF, REF DYNJ69445; 33) C-SECTION PACK-LF, REF DYNJ69445A; 34) C SECTION DELIVERY PACK, REF DYNJ81604A; 35) C SECTION DELIVERY PACK, REF DYNJ81604B; 36) C SECTION PACK, REF DYNJ82949; 37) C-SECTION ADD ON PACK, REF DYNJ83507; 38) C-SECTION PACK, REF DYNJ83980; 39) C SECTION ACCESS, REF DYNJ85612; 40) ISSAQUAH C-SECTION PACK-LF, REF DYNJ85770; 41) C-SECTION PACK, REF DYNJ86173; 42) C-SECTION, REF DYNJ900266F; 43) C-SECTION, REF DYNJ903865D; 44) C-SECTION, REF DYNJ904612G; 45) C-SECTION, REF DYNJ904612I; 46) C-SECTION, REF DYNJ904653G; 47) C-SECTION, REF DYNJ904697F; 48) CDS C-SECTION CH, REF DYNJ906263D; 49) C SECTION, REF DYNJ908327; 50) C-SECTION -LF, REF DYNJ9932207R; 51) C-SECTION -LF, REF DYNJ9932207S; 52) C-SECTION PACK, REF DYNJV0322A; 53) GP-C SECTION PACK-LF, REF PHS396980007C.

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.

  • 10195327209797
  • 40195327209798
  • 10195327139629
  • 40195327139620
  • 10193489645606
  • 40193489645607
  • 10193489958003
  • 40193489958004
  • 10195327206246
  • 40195327206247
  • 10889942826582
  • 40889942826583
  • 10195327561871
  • 40195327561872
  • 10195327349431
  • 40195327349432
  • 10195327496609
  • 40195327496600
  • 10195327351373
  • 40195327351374

Lot or batch code

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

  • 23JBR313
  • 23KBB240
  • 24DBA895
  • 24EBI651
  • 23FBP399
  • 23HBP624
  • 23IBE037
  • 23JBC747
  • 23LBM204
  • 24ABL069
  • 24CBM113
  • 24FBE246
  • 23EDA073
  • 23GBP147
  • 23HBD395
  • 23HBP685
  • 24BBV536
  • 24EBF239
  • 23HMD981
  • 23KBF163

Model or item number

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

  • CDS820075W
  • CDS984261J
  • CDS985282F
  • DYNJ02577D
  • DYNJ0536924U
  • DYNJ0551169V
  • DYNJ0551409P
  • DYNJ07836R
  • DYNJ14103C
  • DYNJ19417R
  • DYNJ33059B
  • DYNJ38063D
  • DYNJ38700G
  • DYNJ38845D
  • DYNJ38845F
  • DYNJ44679L
  • DYNJ47808F
  • DYNJ48087I
  • DYNJ51354B
  • DYNJ52481B

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 10195327209797, 40195327209798, 10195327139629; lot code 23JBR313, 23KBB240, 24DBA895; model number CDS820075W, CDS984261J, CDS985282F. 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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