Class II U.S. Food and Drug Administration

Medline convenience kits labeled as: 1) Neuro Craniotomy CDS #36-RF 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

A fire or burn risk is what prompted this recall. Most of these incidents happen while the product is charging or left running unattended.

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-0530-2026
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
40151 kits
Distribution
Nationwide
Made in
United States
Lot / code info
REF CDS780119V: UDI/DI 10195327114916 (each) 40195327114917 (case), Lot Numbers: 23GBQ904; REF CDS780119V: UDI/DI 10195327114916 (each) 40195327114917 (case), Lot Numbers: 23JBS979; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 23LBD720; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 24BBK043; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 24CBA347; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 24EBM283; REF CDS780147N: UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 24GBB624; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 23GBS348; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 23HBJ325; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 24ABK205; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 24ABW098; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 24BBN591; REF CDS780148R: UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 24CBS634; REF CDS780208I: UDI/DI 10195327525231 (each) 40195327525232 (case), Lot Numbers: 23JBU709; REF CDS920027Y: UDI/DI 10195327298531 (each) 40195327298532 (case), Lot Numbers: 23LBF304; REF CDS920027Y: UDI/DI 10195327298531 (each) 40195327298532 (case), Lot Numbers: 24ABB904; REF CDS920027Y: UDI/DI 10195327298531 (each) 40195327298532 (case), Lot Numbers: 24CBA311; REF CDS940072Y: UDI/DI 10195327300845 (each) 40195327300846 (case), Lot Numbers: 23KBU712; REF CDS940072Y: UDI/DI 10195327300845 (each) 40195327300846 (case), Lot Numbers: 24ABY634; REF CDS940823AB: UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 24ABQ717; REF CDS940823AB: UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 24ABU281; REF CDS940823AB: UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 24CBD739; REF CDS940823AB: UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 24DBP226; REF CDS940843AA: UDI/DI 10195327151409 (each) 40195327151400 (case), Lot Numbers: 24DBD229; REF CDS940843AA: UDI/DI 10195327151409 (each) 40195327151400 (case), Lot Numbers: 24EBM262; REF CDS940843AA: UDI/DI 10195327151409 (each) 40195327151400 (case), Lot Numbers: 24EBV396; REF CDS940963Y: UDI/DI 10193489883671 (each) 40193489883672 (case), Lot Numbers: 24BBO653; REF CDS940963Y: UDI/DI 10193489883671 (each) 40193489883672 (case), Lot Numbers: 24BBV236; REF CDS940963Y: UDI/DI 10193489883671 (each) 40193489883672 (case), Lot Numbers: 24CBS637; REF CDS940963Y: UDI/DI 10193489883671 (each) 40193489883672 (case), Lot Numbers: 24IBD594; REF CDS941065L: UDI/DI 10193489445350 (each) 40193489445351 (case), Lot Numbers: 23GBJ674; REF CDS941065L: UDI/DI 10193489445350 (each) 40193489445351 (case), Lot Numbers: 24ABP205; REF CDS941065L: UDI/DI 10193489445350 (each) 40193489445351 (case), Lot Numbers: 24CBD703; REF CDS941065L: UDI/DI 10193489445350 (each) 40193489445351 (case), Lot Numbers: 24EBT843; REF CDS981923X: UDI/DI 10195327434298 (each) 40195327434299 (case), Lot Numbers: 23HBB366; REF CDS981923X: UDI/DI 10195327434298 (each) 40195327434299 (case), Lot Numbers: 23HBS882; REF CDS982823S: UDI/DI 10195327674403 (each) 40195327674404 (case), Lot Numbers: 24EBL031; REF CDS982943S: UDI/DI 10195327432393 (each) 40195327432394 (case), Lot Numbers: 23HBA580; REF CDS982943S: UDI/DI 10195327432393 (each) 40195327432394 (case), Lot Numbers: 23HBN648; REF CDS982943T: UDI/DI 10195327627003 (each) 40195327627004 (case), Lot Numbers: 24DBW083; REF CDS982943T: UDI/DI 10195327627003 (each) 40195327627004 (case), Lot Numbers: 24GBC807; REF CDS982986U: UDI/DI 10195327554095 (each) 40195327554096 (case), Lot Numbers: 23LBJ387; REF CDS982986U: UDI/DI 10195327554095 (each) 40195327554096 (case), Lot Numbers: 23LBQ432; REF CDS982986U: UDI/DI 10195327554095 (each) 40195327554096 (case), Lot Numbers…
UPC codes
10195327114916, 40195327114917, 10195327268770, 40195327268771, 10195327268787, 40195327268788, 10195327525231, 40195327525232, 10195327298531, 40195327298532, 10195327300845, 40195327300846, 10193489883282, 40193489883283, 10195327151409, 40195327151400, 10193489883671, 40193489883672, 10193489445350, 40193489445351

Products covered by this recall

MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB; 8) TOTAL HIP CDS, REF CDS940843AA; 9) TOTAL HIP CDS, REF CDS940963Y; 10) SHOULDER CDS, REF CDS941065L; 11) LAMINECTOMY CDS-LF, REF CDS981923X; 12) TOTAL KNEE CDS, REF CDS982823S; 13) LOWER EXTREMITY CDS, REF CDS982943S; 14) LOWER EXTREMITY CDS, REF CDS982943T; 15) TOTAL KNEE, REF CDS982986U; 16) EXTREMITY CDS, REF CDS983031Q; 17) PODIATRY CDS, REF CDS983610L; 18) TOTAL HIP CDS-LF, REF CDS983761N; 19) BASIC ORTHO CDS, REF CDS983769L; 20) UPPER EXTREMITY CDS, REF CDS983907L; 21) LOWER EXTREMITY CDS, REF CDS983909P; 22) GENERAL ORTHO CDS, REF CDS983915M; 23) MAJOR ORTHO, REF CDS984253L; 24) LOWER EXTREMTIY, REF CDS984254M; 25) TOTAL KNEE, REF CDS985566R; 26) ORTHO PACK, REF DYNJ00284M; 27) CRANIOTOMY PACK-LF, REF DYNJ0160354C; 28) CRANIOTOMY PACK-LF, REF DYNJ0161342C; 29) CRANIOTOMY PACK-LF, REF DYNJ0161342D; 30) CRANIOTOMY HARPER PACK-LF, REF DYNJ0162022G; 31) SPINE PACK-LF, REF DYNJ0376635P; 32) GP-TOTAL JOINT -LF, REF DYNJ0396868V; 33) GP-EXTREMITY/SHOULDER PACK-LF, REF DYNJ0396906P; 34) EXTREMITY PACK-LF, REF DYNJ0519273N; 35) TOTAL KNEE PACK-LF, REF DYNJ0530895AO; 36) TOTAL KNEE PACK-LF, REF DYNJ0530895AP; 37) UPPER EXTREMITY PACK-LF, REF DYNJ0532846S; 38) LOWER EXTREMITY PACK-LF, REF DYNJ0532852Q; 39) ACL SSC PACK-LF, REF DYNJ0536892U; 40) TOTAL HIP PACK-LF, REF DYNJ0536903AL; 41) TOTAL HIP PACK-LF, REF DYNJ0536903AM; 42) LOWER EXTREMITY PACK-LF, REF DYNJ0587115R; 43) TOTAL HIP PACK-LF, REF DYNJ0618354V; 44) TOTAL KNEE PACK-LF, REF DYNJ0646272S; 45) SPINE ANT POST ADD A PACK-LF, REF DYNJ0753208J; 46) OPEN SHOULDER SSC PACK, REF DYNJ0840659T; 47) TOTAL JOINT PACK-LF, REF DYNJ0885263F; 48) TOTAL KNEE PACK, REF DYNJ21813J; 49) CRANIO/MAXILOFACIAL #49-RF, REF DYNJ21826R; 50) TOTAL HIP PACK, REF DYNJ27315K; 51) PODIATRY PACK, REF DYNJ33978K; 52) LOWER EXTREMITY, REF DYNJ34420N; 53) LOWER EXTREMITY, REF DYNJ34420O; 54) GENERAL ORTHO, REF DYNJ34428O; 55) ARTHROSCOPY PACK, REF DYNJ35835G; 56) HAND PACK, REF DYNJ37697J; 57) ACH SPINE PACK, REF DYNJ38042K; 58) SHOULDER ARTHROSCOPY PACK, REF DYNJ38224C; 59) LAMINECTOMY PACK, REF DYNJ38227C; 60) EXTREMITY PACK, REF DYNJ38234G; 61) TOTAL JOINT PACK, REF DYNJ40982D; 62) SPINE PACK, REF DYNJ40995B; 63) EXTREMITY PACK, REF DYNJ41416G; 64) TOTAL JOINT PACK, REF DYNJ42793D; 65) CRANIOTOMY PACK-LF, REF DYNJ43208G; 66) HIP I PACK-LF, REF DYNJ43215I; 67) LAMINECTOMY PACK-LF, REF DYNJ43218G; 68) LIMB PACK-LF, REF DYNJ43220G; 69) SPLIT PACK-LF, REF DYNJ43225G; 70) TOTAL KNEE PACK-LF, REF DYNJ43226I; 71) EXTREMITY PACK, REF DYNJ44681J; 72) SHOULDER PACK, REF DYNJ44685L; 73) TOTAL KNEE PACK, REF DYNJ44687L; 74) UPPER EXTREMITY PACK, REF DYNJ44688I; 75) PODIATRY PACK, REF DYNJ44692G; 76) ACL PACK, REF DYNJ44849F; 77) CENTRACARE PLAZA-MINOR ORTHO, REF DYNJ44860I; 78) MAJOR EXTREMITY, REF DYNJ44878D; 79) ORTHO HIP, REF DYNJ44884G; 80) EXTREMITY PACK, REF DYNJ45332G;

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.

  • 10195327114916
  • 40195327114917
  • 10195327268770
  • 40195327268771
  • 10195327268787
  • 40195327268788
  • 10195327525231
  • 40195327525232
  • 10195327298531
  • 40195327298532
  • 10195327300845
  • 40195327300846
  • 10193489883282
  • 40193489883283
  • 10195327151409
  • 40195327151400
  • 10193489883671
  • 40193489883672
  • 10193489445350
  • 40193489445351

Lot or batch code

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

  • 23GBQ904
  • 23JBS979
  • 23LBD720
  • 24BBK043
  • 24CBA347
  • 24EBM283
  • 24GBB624
  • 23GBS348
  • 23HBJ325
  • 24ABK205
  • 24ABW098
  • 24BBN591
  • 24CBS634
  • 23JBU709
  • 23LBF304
  • 24ABB904
  • 24CBA311
  • 23KBU712
  • 24ABY634
  • 24ABQ717

Model or item number

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

  • CDS780119V
  • CDS780147N
  • CDS780148R
  • CDS780208I
  • CDS920027Y
  • CDS940072Y
  • CDS940823AB
  • CDS940843AA
  • CDS940963Y
  • CDS941065L
  • CDS981923X
  • CDS982823S
  • CDS982943S
  • CDS982943T
  • CDS982986U
  • CDS983031Q
  • CDS983610L
  • CDS983761N
  • CDS983769L
  • CDS983907L

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 — A fire or burn risk is what prompted this recall. Most of these incidents happen while the product is charging or left running unattended.

  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.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.

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 10195327114916, 40195327114917, 10195327268770; lot code 23GBQ904, 23JBS979, 23LBD720; model number CDS780119V, CDS780147N, CDS780148R. 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?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls