Class II U.S. Food and Drug Administration

Medline convenience kits labeled as: 1) Major Laparotomy 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-0517-2026
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
28679 kits
Distribution
Nationwide
Made in
United States
Lot / code info
REF CDS860015W: UDI/DI 10195327349509 (each) 40195327349500, (case), Lot Numbers: CDS860015W; REF CDS860015W: UDI/DI 10195327349509 (each) 40195327349500, (case), Lot Numbers: CDS860015W; REF CDS860015W: UDI/DI 10195327349509 (each) 40195327349500, (case), Lot Numbers: CDS860015W; REF CDS860015X: UDI/DI 10195327647513 (each) 40195327647514, (case), Lot Numbers: CDS860015X; REF CDS860015X: UDI/DI 10195327647513 (each) 40195327647514, (case), Lot Numbers: CDS860015X; REF CDS860015X: UDI/DI 10195327647513 (each) 40195327647514, (case), Lot Numbers: CDS860015X; REF CDS860016R: UDI/DI 10195327349479 (each) 40195327349470, (case), Lot Numbers: CDS860016R; REF CDS860016S: UDI/DI 10195327647520 (each) 40195327647521, (case), Lot Numbers: CDS860016S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860062S: UDI/DI 10195327140632 (each) 40195327140633, (case), Lot Numbers: CDS860062S; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS860194I: UDI/DI 10193489445152 (each) 40193489445153, (case), Lot Numbers: CDS860194I; REF CDS920080T: UDI/DI 10195327349486 (each) 40195327349487, (case), Lot Numbers: CDS920080T; REF CDS920080T: UDI/DI 10195327349486 (each) 40195327349487, (case), Lot Numbers: CDS920080T; REF CDS920080T: UDI/DI 10195327349486 (each) 40195327349487, (case), Lot Numbers: CDS920080T; REF CDS920080T: UDI/DI 10195327349486 (each) 40195327349487, (case), Lot Numbers: CDS920080T; REF CDS930027V: UDI/DI 10195327241759 (each) 40195327241750, (case), Lot Numbers: CDS930027V; REF CDS930027V: UDI/DI 10195327241759 (each) 40195327241750, (case), Lot Numbers: CDS930027V; REF CDS930027V: UDI/DI 10195327241759 (each) 40195327241750, (case), Lot Numbers: CDS930027V; REF CDS930027X: UDI/DI 10195327647698 (each) 40195327647699, (case), Lot Numbers: CDS930027X; REF CDS980246V: UDI/DI 10193489848342 (each) 40193489848343, (case), Lot Numbers: CDS980246V; REF CDS980246V: UDI/DI 10193489848342 (each) 40193489848343, (case), Lot Numbers: CDS980246V; REF CDS980246V: UDI/DI 10193489848342 (each) 40193489848343, (case), Lot Numbers: CDS980246V; REF CDS982936V: UDI/DI 10195327627324 (each) 40195327627325, (case), Lot Numbers: CDS982936V; REF CDS983759L: UDI/DI 10195327451233 (each) 40195327451234, (case), Lot Numbers: CDS983759L; REF CDS983759L: UDI/DI 10195327451233 (each) 40195327451234, (case), Lot Numbers: CDS983759L; REF CDS983759L: UDI/DI 10195327451233 (each) 40195327451234, (case), Lot Numbers: CDS983759L; REF CDS983759L: UDI/DI 10195327451233 (each) 40195327451234, (case), Lot Numbers: CDS983759L; REF CDS983914L: UDI/DI 10195327238360 (each) 40195327238361, (case), Lot Numbers: CDS983914L; REF CDS983914L: UDI/DI 10195327238360 (each) 40195327238361, (case), Lot Numbers: CDS983914L; REF CDS983914L: UDI/DI 10195327238360 (each) 40195327238361, (case), Lot Numbers: CDS983914L; REF CDS984251N: UDI/DI 10193489862218 (each) 40193489862219, (case), Lot Numbers: CDS984251N; REF CDS984251N: UDI/DI 10193489862218 (each) 40193489862219, (case), Lot Numbers: CDS984251N; REF CDS985451G: UDI/DI 10195327237639 (each) 40195327237630, (case), Lot Numbers: CDS985451G; REF DYNJ00210N: UDI/DI 10195327412012 (each) 40195327412013, (case), Lot Numbers: DYNJ00210N; REF DYNJ00210N: UDI/DI 10195327412012 (each) 401953…
UPC codes
10195327349509, 40195327349500, 10195327647513, 40195327647514, 10195327349479, 40195327349470, 10195327647520, 40195327647521, 10195327140632, 40195327140633, 10193489445152, 40193489445153, 10195327349486, 40195327349487, 10195327241759, 40195327241750, 10195327647698, 40195327647699, 10193489848342, 40193489848343

Products covered by this recall

MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS, REF CDS860016R; 4) MINOR LAPAROTOMY CDS, REF CDS860016S; 5) LAPAROTOMY CDS #31-RF, REF CDS860062S; 6) LAPAROSCOPY CDS, REF CDS860194I; 7) BASIC LAPAROSCOPY CDS, REF CDS920080T; 8) GENERAL LAPAROSCOPY, REF CDS930027V; 9) GENERAL LAPAROSCOPY, REF CDS930027X; 10) GENERAL MINOR CDS, REF CDS980246V; 11) BASIC CDS, REF CDS982936V; 12) MAJOR ABDOMINAL CDS, REF CDS983759L; 13) GENERAL SURGERY CDS, REF CDS983914L; 14) GENERAL LAP, REF CDS984251N; 15) ACH MINOR PROCEDURE, REF CDS985451G; 16) SCOPE LAP THOR PACK, REF DYNJ00210N; 17) MAJOR LAPAROTOMY PACK, REF DYNJ00387P; 18) MAJOR ABDOMINAL HARPER PACK-LF, REF DYNJ0160657D; 19) LAPAROTOMY PACK-LF, REF DYNJ0161299C; 20) LAPAROTOMY PACK-LF, REF DYNJ0311538N; 21) MAJOR PACK-LF, REF DYNJ0386381L; 22) DONOR FREE FLAP PACK-LF, REF DYNJ0426069N; 23) LAPAROTOMY PACK-LF, REF DYNJ0519288N; 24) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401S; 25) MAJOR LAPAROTOMY PACK, REF DYNJ20819M; 26) MAJOR ABDOMINAL, REF DYNJ23429G; 27) MINI LAPAROTOMY #16-RF, REF DYNJ27322S; 28) MINI LAPAROTOMY #16-RF, REF DYNJ27322T; 29) TN LAPAROTOMY PACK-LF, REF DYNJ34206I; 30) LAPAROTOMY, REF DYNJ34424N; 31) COREWELL TSC- LAP PACK-LF, REF DYNJ37100I; 32) GENERAL LAP PACK, REF DYNJ38223C; 33) LAP CHOLE PACK, REF DYNJ38228C; 34) MINOR PACK, REF DYNJ41418I; 35) GENERAL PACK-LF, REF DYNJ43213J; 36) HERNIA PACK, REF DYNJ44683L; 37) GENERAL ABDOMINAL, REF DYNJ44870J; 38) LAP CHOLE PACK, REF DYNJ44873I; 39) LAP RENAL PACK, REF DYNJ44875O; 40) MAJOR LAPAROTOMY, REF DYNJ45334G; 41) MAJOR LAPAROTOMY, REF DYNJ45334J; 42) MINOR PROCEDURE, REF DYNJ45336J; 43) MINOR PROCEDURE PACK, REF DYNJ47057D; 44) MINOR PROCEDURE PACK, REF DYNJ47057F; 45) MAJOR BASIC PACK (MBGSE)227-LF, REF DYNJ47696J; 46) LAP CHOLE PACK, REF DYNJ48092G; 47) LAPAROTOMY PACK, REF DYNJ48093F; 48) ISS GENERAL PACK, REF DYNJ48921I; 49) MINOR UROLOGY PACK, REF DYNJ49310F; 50) HERNIA SGM PACK-LF, REF DYNJ51434B; 51) MINOR GENERAL PACK, REF DYNJ52329C; 52) MINOR GENERAL PACK, REF DYNJ52329D; 53) MINOR GENERAL PACK, REF DYNJ52329F; 54) MINOR LAPAROTOMY PACK-LF, REF DYNJ52863D; 55) MINOR GENERAL PACK, REF DYNJ53036G; 56) MINOR GENERAL PACK, REF DYNJ53036I; 57) IPP PENILE PROSTHESIS PACK, REF DYNJ58061J; 58) MAJOR LAPAROTOMY PACK, REF DYNJ58561D; 59) MAJOR LAPAROTOMY PACK, REF DYNJ58561F; 60) MINOR PACK, REF DYNJ58562D; 61) MINOR PACK, REF DYNJ58562F; 62) MINOR GENERAL PACK, REF DYNJ59358D; 63) PACK HERNIA INGUINAL, REF DYNJ60145B; 64) PK CUST MAJOR ST MICHAEL, REF DYNJ60782B; 65) CENTRACARE PLAZA-LAP CHOLE PK, REF DYNJ61620C; 66) MINOR GEN PACK, REF DYNJ61661A; 67) SLCH MAJOR GENERAL PACK, REF DYNJ61666A; 68) DAVINCI PROSTATE PACK, REF DYNJ61711B; 69) THORACIC PACK, REF DYNJ62015C; etc

Check your product

The notice names 56 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.

  • 10195327349509
  • 40195327349500
  • 10195327647513
  • 40195327647514
  • 10195327349479
  • 40195327349470
  • 10195327647520
  • 40195327647521
  • 10195327140632
  • 40195327140633
  • 10193489445152
  • 40193489445153
  • 10195327349486
  • 40195327349487
  • 10195327241759
  • 40195327241750
  • 10195327647698
  • 40195327647699
  • 10193489848342
  • 40193489848343

Lot or batch code

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

  • CDS860015W
  • CDS860015X
  • CDS860016R
  • CDS860016S
  • CDS860062S
  • CDS860194I
  • CDS920080T
  • CDS930027V
  • CDS930027X
  • CDS980246V
  • CDS982936V
  • CDS983759L
  • CDS983914L
  • CDS984251N
  • CDS985451G
  • DYNJ00210N

Model or item number

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

  • CDS860015W
  • CDS860015X
  • CDS860016R
  • CDS860016S
  • CDS860062S
  • CDS860194I
  • CDS920080T
  • CDS930027V
  • CDS930027X
  • CDS980246V
  • CDS982936V
  • CDS983759L
  • CDS983914L
  • CDS984251N
  • CDS985451G
  • DYNJ00210N
  • DYNJ00387P
  • DYNJ0160657D
  • DYNJ0161299C
  • DYNJ0311538N

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 10195327349509, 40195327349500, 10195327647513; lot code CDS860015W, CDS860015X, CDS860016R; model number CDS860015W, CDS860015X, CDS860016R. 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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