Class II U.S. Food and Drug Administration

Medline convenience kits labeled as: 1) General Laparoscopy 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-0521-2026
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
20941 kits
Distribution
Nationwide
Made in
United States
Lot / code info
REF 24BBC860: UDI/DI 10195327601492 (each), 40195327601493 (case), Lot Numbers: 24BBC860; REF 24BBU607: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24BBU607; REF 24CBU583: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24CBU583; REF 24EBE546: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24EBE546; REF 23GBF733: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 23GBF733; REF 24ABG140: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24ABG140; REF 24BBN521: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24BBN521; REF 24CBR696: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24CBR696; REF 24EBK857: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24EBK857; REF 24ABH200: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24ABH200; REF 24BBG787: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24BBG787; REF 24CBI679: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24CBI679; REF 23GBS700: UDI/DI 10195327185220 (each), 40195327185221 (case), Lot Numbers: 23GBS700; REF 24ABG363: UDI/DI 10195327185220 (each), 40195327185221 (case), Lot Numbers: 24ABG363; REF 24BBH950: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24BBH950; REF 24BBR420: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24BBR420; REF 24CBV474: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24CBV474; REF 24EBS619: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24EBS619; REF 24ABQ767: UDI/DI 10195327584450 (each), 40195327584451 (case), Lot Numbers: 24ABQ767; REF 24ABS333: UDI/DI 10195327584450 (each), 40195327584451 (case), Lot Numbers: 24ABS333; REF 24EBP558: UDI/DI 10195327584450 (each), 40195327584451 (case), Lot Numbers: 24EBP558; REF 24ABL655: UDI/DI 10195327584511 (each), 40195327584512 (case), Lot Numbers: 24ABL655; REF 24CBI698: UDI/DI 10195327584511 (each), 40195327584512 (case), Lot Numbers: 24CBI698; REF 24EBJ019: UDI/DI 10195327584511 (each), 40195327584512 (case), Lot Numbers: 24EBJ019; REF 24FBE329: UDI/DI 10195327584474 (each), 40195327584475 (case), Lot Numbers: 24FBE329; REF 24FBI206: UDI/DI 10195327584474 (each), 40195327584475 (case), Lot Numbers: 24FBI206; REF 24BBC411: UDI/DI 10195327584467 (each), 40195327584468 (case), Lot Numbers: 24BBC411; REF 24CBD731: UDI/DI 10195327584467 (each), 40195327584468 (case), Lot Numbers: 24CBD731; REF 24EBM175: UDI/DI 10195327584467 (each), 40195327584468 (case), Lot Numbers: 24EBM175; REF 24BBF155: UDI/DI 10195327601485 (each), 40195327601486 (case), Lot Numbers: 24BBF155; REF 24CBU894: UDI/DI 10195327601485 (each), 40195327601486 (case), Lot Numbers: 24CBU894; REF 24FBE659: UDI/DI 10195327601485 (each), 40195327601486 (case), Lot Numbers: 24FBE659; REF 24BBE394: UDI/DI 10195327601508 (each), 40195327601509 (case), Lot Numbers: 24BBE394; REF 24BBO665: UDI/DI 10195327601508 (each), 40195327601509 (case), Lot Numbers: 24BBO665; REF 24BBV851: UDI/DI 10195327601508 (each), 40195327601509 (case), Lot Numbers: 24BBV851; REF 23EMF844: UDI/DI 10195327412029 (each), 40195327412020 (case), Lot Numbers: 23EMF844; REF 23HMD598: UDI/DI 10195327412029 (each), 40195327412020 (case), Lot Numbers: 23HMD598; REF 23FDA733: UDI/DI 10195327404550 (each), 40195327404551 (case), Lot Numbers: 23FDA733; REF 23HDB247: UDI/DI 10195327404550 (each), 40195327404551 (case), Lot Numbers: 23HDB247; REF 23EDA481: UDI/DI 10195327404574 (each), 40195327404575 (case), Lot Numbers: 23EDA481; REF 23FDA681: UDI/DI 10195327404574 (each), 40195327404575 (case), Lot Numbers: 23FDA681; REF 23FDB248: UDI/DI 10195327304331 (each), 40195327304332 (case), Lot Numbers: 23FDB248; REF 23FDB439: UDI/DI 10195327304331 (each), 40195327304332 (case), Lot Numbers: 23FDB439; REF 23FDC293: UDI/DI 10195327304331 (each), 40195327304332 (case), Lot Numbers: 23FDC293; REF 23JMD699: UDI/DI 10195327356750 (ea…
UPC codes
10195327601492, 40195327601493, 10193489848434, 40193489848435, 10193489445442, 40193489445443, 10195327584481, 40195327584482, 10195327185220, 40195327185221, 10195327584498, 40195327584499, 10195327584450, 40195327584451, 10195327584511, 40195327584512, 10195327584474, 40195327584475, 10195327584467, 40195327584468

Products covered by this recall

MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJOR ABDOMINAL CDS, REF CDS983908Q; 8) LOWER EXTREMITY CDS, REF CDS983909Q; 9) GENERAL SURGERY CDS, REF CDS983914M; 10) GENERAL ORTHO CDS, REF CDS983915N; 11) GENERAL LAP, REF CDS984251O; 12) ROBOTIC, REF CDS984262O; 13) HYPOSPADIUS PACK, REF DYNJ00282Q; 14) MINOR HARPER PACK-LF, REF DYNJ0161694F; 15) THROMBECTOMY HARPER PACK-LF, REF DYNJ0161832F; 16) MAJOR COMPONENT HARPER PACK-LF, REF DYNJ0161949C; 17) MINOR PACK-LF, REF DYNJ0259893T; 18) TOTAL KNEE PACK LF, REF DYNJ0368519AA; 19) TOTAL KNEE PACK LF, REF DYNJ0368519Y; 20) PEDIATRIC BASIC PACK-LF, REF DYNJ0406353N; 21) DONOR FREE FLAP PACK-LF, REF DYNJ0426069O; 22) DONOR FREE FLAP PACK-LF, REF DYNJ0426069P; 23) VASCULAR PACK-LF, REF DYNJ0429345R; 24) GENERAL PACK-LF, REF DYNJ0506906S; 25) BASIC PACK-LF, REF DYNJ0519294K; 26) TOTAL HIP PACK-LF, REF DYNJ0537284AC; 27) TOTAL HIP PACK-LF, REF DYNJ0537284AD; 28) BASIC MAJOR PACK-LF, REF DYNJ0537337AA; 29) BASIC MAJOR PACK-LF, REF DYNJ0537337Y; 30) BASIC GENERAL PACK-LF, REF DYNJ14004N; 31) MVFF/FIBU #54-RF, REF DYNJ21927S; 32) AUGMENTATION #87-RF, REF DYNJ27319W; 33) BASIC SET-UP, REF DYNJ34979B; 34) BASIC PACK, REF DYNJ35834D; 35) MINOR SINGLE BASIN PACK, REF DYNJ37698M; 36) ISSAQUAH PEDIATRIC PACK, REF DYNJ39001F; 37) TOTAL JOINT PACK, REF DYNJ40982F; 38) BASIC PACK, REF DYNJ42791F; 39) TOTAL JOINT PACK, REF DYNJ42793F; 40) RRP PACK, REF DYNJ44109F; 41) CENTRACARE BASIC PACK, REF DYNJ44858J; 42) DONOR PACK, REF DYNJ44865G; 43) UROLOGY RECONSTRUCTION PACK, REF DYNJ44866P; 44) UROLOGY PACK, REF DYNJ44899R; 45) ENDOCRINE PACK-RF, REF DYNJ47131F; 46) ENDOCRINE PACK-RF, REF DYNJ47131G; 47) ORTHO MAJOR, REF DYNJ48131K; 48) ENDO BLADDER PACK, REF DYNJ49672M; 49) ORTHO SPINE SUPPLEMENT PACK-LF, REF DYNJ51445B; 50) MINOR GENERAL PACK, REF DYNJ53036J; 51) ACL PACK, REF DYNJ54634I; 52) READY SET CLOSE PACK, REF DYNJ57214C; 53) KIDNEY TRANSPLANT, REF DYNJ57455C; 54) TOTAL HIP PACK, REF DYNJ58563F; 55) TOTAL HIP PACK, REF DYNJ58563G; 56) TOTAL KNEE PACK, REF DYNJ58564F; 57) TRANSPLANT PACK, REF DYNJ59201D; 58) PACK RECTAL, REF DYNJ60156C; 59) C-SECTION PK CABRINI, REF DYNJ60577B; 60) MINI KIT PACK CABRINI, REF DYNJ60579B; 61) MAJOR GENERAL CHRISTUS, REF DYNJ61184D; 62) PK CUST BASIC PK CHRISTUS, REF DYNJ61647B; 63) THORACIC PACK, REF DYNJ62015B; 64) MAJOR GENERAL PACK, REF DYNJ62397B; 65) VASCULAR PACK, REF DYNJ62683D; 66) GENDER AFFIRMING SURGERY, REF DYNJ66252C; 67) GENDER AFFIRMING SURGERY, REF

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.

  • 10195327601492
  • 40195327601493
  • 10193489848434
  • 40193489848435
  • 10193489445442
  • 40193489445443
  • 10195327584481
  • 40195327584482
  • 10195327185220
  • 40195327185221
  • 10195327584498
  • 40195327584499
  • 10195327584450
  • 40195327584451
  • 10195327584511
  • 40195327584512
  • 10195327584474
  • 40195327584475
  • 10195327584467
  • 40195327584468

Lot or batch code

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

  • 24BBC860
  • 24BBU607
  • 24CBU583
  • 24EBE546
  • 23GBF733
  • 24ABG140
  • 24BBN521
  • 24CBR696
  • 24EBK857
  • 24ABH200
  • 24BBG787
  • 24CBI679
  • 23GBS700
  • 24ABG363
  • 24BBH950
  • 24BBR420
  • 24CBV474
  • 24EBS619
  • 24ABQ767
  • 24ABS333

Model or item number

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

  • CDS930027W
  • CDS980245X
  • CDS980566F
  • CDS982823R
  • CDS982936U
  • CDS983907M
  • CDS983908Q
  • CDS983909Q
  • CDS983914M
  • CDS983915N
  • CDS984251O
  • CDS984262O
  • DYNJ00282Q
  • DYNJ0161694F
  • DYNJ0161832F
  • DYNJ0161949C
  • DYNJ0259893T
  • DYNJ0368519AA
  • DYNJ0368519Y
  • DYNJ0406353N

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. Do not leave it charging overnight or while the house is empty while you wait for the remedy.
  3. If it has already overheated, scorched or swelled, do not keep using it and do not try to repair it.
  4. Check that your smoke alarms work while you are thinking about it, and follow the remedy on this page.

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.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.
  • 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.

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 10195327601492, 40195327601493, 10193489848434; lot code 24BBC860, 24BBU607, 24CBU583; model number CDS930027W, CDS980245X, CDS980566F. 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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