Class II U.S. Food and Drug Administration

Medline convenience kits labeled as: 1) General AAA #11-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

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-0513-2026
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
5133 kits
Distribution
Nationwide
Made in
United States
Lot / code info
1) CDS840261AB: UDI/DI 10195327104535 (each), 40195327104536 (case), Lot Numbers: 23FBF165, 23JBM632. 2) CDS983637I: UDI/DI 10195327228125 (each), 40195327228126 (case), Lot Numbers: 23GBU191. 3) CDS983723J: UDI/DI 10195327327828 (each), 40195327327829 (case), Lot Numbers: 23FBA013, 23FBH486, 23GBE805. 4) CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Numbers: 23GBT133, 23HBH924, 23HBL135, 23HBV936. 5) CDS984255K: UDI/DI 10193489288605 (each), 40193489288606 (case), Lot Numbers: 23KBU348, 24ABB883, 24ABS338. 6) DYNJ0161262C: UDI/DI 10195327357283 (each), 40195327357284 (case), Lot Numbers: 23GDB197, 23GDB757. 7) DYNJ0421380P: UDI/DI 10195327084271 (each), 40195327084272 (case), Lot Numbers: 23DMI590, 23FMJ656. 8) DYNJ21877W: UDI/DI 10195327104542 (each), 40195327104543 (case), Lot Numbers: 23FBT682, 23GBF898, 23IBC645, 24ABR316. 9) DYNJ22350L: UDI/DI 10193489445251 (each), 40193489445252 (case), Lot Numbers: 23LBU055, 24BBQ300. 10) DYNJ27432AC: UDI/DI 10195327104511 (each), 40195327104512 (case), Lot Numbers: 23EBU150, 23GBF873, 23HBQ650, 23IBB637. 11) DYNJ37284K: UDI/DI 10195327401030 (each), 40195327401031 (case), Lot Numbers: 23IBP124, 23KBF938, 24ABS487. 12) DYNJ38175L: UDI/DI 10195327227906 (each), 40195327227907 (case), Lot Numbers: 23FLA915, 23ILA168. 13) DYNJ42921G: UDI/DI 10193489981384 (each), 40193489981385 (case), Lot Numbers: 23FBU282, 23IBT172. 14) DYNJ43207K: UDI/DI 10193489952926 (each), 40193489952927 (case), Lot Numbers: 23EME962. 15) DYNJ43214F: UDI/DI 10193489953077 (each), 40193489953078 (case), Lot Numbers: 23EMA158. 16) DYNJ44847I: UDI/DI 10195327127558 (each), 40195327127559 (case), Lot Numbers: 23HLA758, 23HLB101, 23LLA759. 17) DYNJ44857U: UDI/DI 10195327298067 (each), 40195327298068 (case), Lot Numbers: 23GBI967, 23GBQ950. 18) DYNJ44869K: UDI/DI 10195327127657 (each), 40195327127658 (case), Lot Numbers: 23GBI967, 23GBQ950, 23KMC104. 19) DYNJ44879K: UDI/DI 10195327282233 (each), 40195327282234 (case), Lot Numbers: 23DBI854, 23EBH319, 23GBT541. 20) DYNJ44886M: UDI/DI 10195327127749 (each), 40195327127740 (case), Lot Numbers: 23DBN895, 23EBU129, 23FBQ134, 23GBQ953, 23HBT951. 21) DYNJ50528M: UDI/DI 10195327129699 (each), 40195327129690 (case), Lot Numbers: 23EBA780, 23EBS770, 23GBT274. 22) DYNJ51038R: UDI/DI 10195327298258 (each), 40195327298259 (case), Lot Numbers: 23HBD834. 23) DYNJ56838F: UDI/DI 10195327277857 (each), 40195327277858 (case), Lot Numbers: 23GDA228, 23HDA839. 24) DYNJ56839D: UDI/DI 10195327277864 (each), 40195327277865 (case), Lot Numbers: 23GDA320. 25) DYNJ60548B: UDI/DI 10195327361761 (each), 40195327361762 (case), Lot Numbers: 23EBD777, 23IBS545, 23JBJ740. 26) DYNJ60783B: UDI/DI 10195327361846 (each), 40195327361847 (case), Lot Numbers : 23EBR616, 23GBW384, 23IBV398. 27) DYNJ61659A: UDI/DI 10193489929638 (each), 40193489929639 (case), Lot Numbers: 23HBI627. 28) DYNJ62097C: UDI/DI 10195327189839 (each), 40195327189830 (case), Lot Numbers: 23DBJ117, 23EBD473, 23HBQ663, 23IBB641. 29) DYNJ65039C: UDI/DI 10195327528256 (each), 40195327528257 (case), Lot Numbers: 24BMF955, 24CMB409, 24CME382, 24FMH176. 30) DYNJ66033B: UDI/DI 10195327680589 (each), 40195327680580 (case), Lot Numbers: 24EBA176. 31) DYNJ80609D: UDI/DI 10195327298296 (each), 40195327298297 (case), Lot Numbers: 23HBR318, 23HBZ183. 32) DYNJ81581B: UDI/DI 10195327379254 (each), 40195327379255 (case), Lot Numbers: 23EBO537, 23GBQ499, 23HBG425. 33) DYNJ81605: UDI/DI 10195327123888 (each), 40195327123889 (case), Lot Numbers: 23DBL829, 23EBI374, 23EBM656. 34) DYNJ81610B: UDI/DI 10195327398316 (each), 40195327398317 (case), Lot Numbers: 23EBA748, 23IBP506. 35) DYNJ82166: UDI/DI 10195327182564 (each), 40195327182565 (case), Lot Numbers: 23FDA955. 36) DYNJ82217: UDI/DI 10195327183585 (each), 40195327183586 (case), Lot Numbers: 23DDB931, 23HDA667. 37) DYNJ84017B: UDI/DI 10198459253089 (each), 40198459253080 (case), Lot Numbers: 25CMF132. 38) DYNJ85109: UDI/DI 10195327460594 (each), 40195327460595 (case), Lot Numbers:…
UPC codes
10195327104535, 40195327104536, 10195327228125, 40195327228126, 10195327327828, 40195327327829, 10195327233617, 40195327233618, 10193489288605, 40193489288606, 10195327357283, 40195327357284, 10195327084271, 40195327084272, 10195327104542, 40195327104543, 10193489445251, 40193489445252, 10195327104511, 40195327104512

Products covered by this recall

MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C; 7) VASCULAR PACK-LF, REF DYNJ0421380P; 8) GEN FEM POP #14-RF, REF DYNJ21877W; 9) VASCULAR PACK, REF DYNJ22350L; 10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 11) OPEN HEART PACK, REF DYNJ37284K; 12) ACH CABG ADD-ON, REF DYNJ38175L; 13) CARDIOVASCULAR PACK, REF DYNJ42921G; 14) CABG PACK-LF, REF DYNJ43207K; 15) HEART DRAPING PACK-LF, REF DYNJ43214F; 16) AAA PACK, REF DYNJ44847I; 17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U; 18) FISTULA PACK, REF DYNJ44869K; 19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K; 20) PERMANENT PACING, REF DYNJ44886M; 21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M; 22) DR DANIELSON AC PACK, REF DYNJ51038R; 23) VASCULAR CAROTID PACK, REF DYNJ56838F; 24) VASCULAR FEM PACK, REF DYNJ56839D; 25) PK CUST OPEN HEART A AND B, REF DYNJ60548B; 26) PK CUST CAROTID ST MICHAE, REF DYNJ60783B; 27) CAROTID PACK, REF DYNJ61659A; 28) VASCULAR MINOR PACK, REF DYNJ62097C; 29) VASCULAR PACK-LF, REF DYNJ65039C; 30) PACEMAKER PACK, REF DYNJ66033B; 31) DR MELLINGER AC PACK, REF DYNJ80609D; 32) HEART PACK II, REF DYNJ81581B; 33) AV FISTULA PACK, REF DYNJ81605; 34) MAJOR VASCULAR PACK, REF DYNJ81610B; 35) CABG ACCESSORY PACK, REF DYNJ82166; 36) VALVE ACCESSORY PACK, REF DYNJ82217; 37) PERIVASCULAR CUSTOM PACK, REF DYNJ84017B; 38) CAROTID ENDARTERECTOMY PACK-LF, REF DYNJ85109; 39) ACH OPEN HEART A&B PK, REF DYNJ85110; 40) VASCULAR ABDOMINAL PACK, REF DYNJ85118; 41) AV FISTULA PACK-LF, REF DYNJ85121; 42) CARDIAC - DEEIK PACK, REF DYNJ85637; 43) VASCULAR, REF DYNJ900293K; 44) VASCULAR-LF, REF DYNJ900714C; 45) HEART/MAJOR VASCULAR, REF DYNJ901066K; 46) MODULE OPEN HEART, REF DYNJ903042P; 47) VASCULAR/OR ANGIO, REF DYNJ905079F; 48) OPEN HEART, REF DYNJ905497B; 49) AAA, REF DYNJ906175B; 50) VASCULAR ABDOMINAL, REF DYNJ907105D; 51) CV COMPLETE, REF DYNJ907904A; 52) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820; 53) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820A.

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.

  • 10195327104535
  • 40195327104536
  • 10195327228125
  • 40195327228126
  • 10195327327828
  • 40195327327829
  • 10195327233617
  • 40195327233618
  • 10193489288605
  • 40193489288606
  • 10195327357283
  • 40195327357284
  • 10195327084271
  • 40195327084272
  • 10195327104542
  • 40195327104543
  • 10193489445251
  • 40193489445252
  • 10195327104511
  • 40195327104512

Lot or batch code

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

  • 23FBF165
  • 23JBM632. 2
  • 23GBU191. 3
  • 23FBA013
  • 23FBH486
  • 23GBE805. 4
  • 23GBT133
  • 23HBH924
  • 23HBL135
  • 23HBV936. 5
  • 23KBU348
  • 24ABB883
  • 24ABS338. 6
  • 23GDB197
  • 23GDB757. 7
  • 23DMI590
  • 23FMJ656. 8
  • 23FBT682
  • 23GBF898
  • 23IBC645

Model or item number

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

  • CDS840261AB
  • CDS983637I
  • CDS983723J
  • CDS983773J
  • CDS984255K
  • DYNJ0161262C
  • DYNJ0421380P
  • DYNJ21877W
  • DYNJ22350L
  • DYNJ27432AC
  • DYNJ37284K
  • DYNJ38175L
  • DYNJ42921G
  • DYNJ43207K
  • DYNJ43214F
  • DYNJ44847I
  • DYNJ44857U
  • DYNJ44869K
  • DYNJ44879K
  • DYNJ44886M

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. Move it off anything that burns — a bed, a sofa, a carpet, a pile of paper — and away from exits.
  3. Do not leave it charging overnight or while the house is empty while you wait for the remedy.
  4. If it has already overheated, scorched or swelled, do not keep using it and do not try to repair it.

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.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.
  • 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.

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 10195327104535, 40195327104536, 10195327228125; lot code 23FBF165, 23JBM632. 2, 23GBU191. 3; model number CDS840261AB, CDS983637I, CDS983723J. 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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