Class II U.S. Food and Drug Administration

Medline convenience kits labeled as: 1) ACH Plastics Breast-Lf 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

This product can overheat or catch fire, which is why the instruction is to unplug and stop using it rather than to keep an eye on 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-0519-2026
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
4214 kits
Distribution
Nationwide
Made in
United States
Lot / code info
REF CDS983639K: UDI/DI 10195327351533 (each), 40195327351534 (case), Lot Number 23FBP157; REF CDS983639K: UDI/DI 10195327351533 (each), 40195327351534 (case), Lot Number 23GBM569; REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 23LBN523; REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 24BBA266; REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 24CBS676; REF CDS984267J: UDI/DI 10193489288872 (each), 40193489288873 (case), Lot Number 24EBM454; REF DYNJ00264M: UDI/DI 10195327418717 (each), 40195327418718 (case), Lot Number 23HMA639; REF DYNJ00264M: UDI/DI 10195327418717 (each), 40195327418718 (case), Lot Number 23HMF507; REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23GMI327; REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23JMC006; REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23LMA065; REF DYNJ0428947L: UDI/DI 10195327329136 (each), 40195327329137 (case), Lot Number 23LMC367; REF DYNJ0428947M: UDI/DI 10195327586683 (each), 40195327586684 (case), Lot Number 24DMF699; REF DYNJ0428947M: UDI/DI 10195327586683 (each), 40195327586684 (case), Lot Number 24EMA236; REF DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case), Lot Number 23GBI654; REF DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case), Lot Number 23GBJ925; REF DYNJ27319V: UDI/DI 10195327208127 (each), 40195327208128 (case), Lot Number 23HBZ090; REF DYNJ33977M: UDI/DI 10195327422523 (each), 40195327422524 (case), Lot Number 23HBB046; REF DYNJ44852M: UDI/DI 10195327325220 (each), 40195327325221 (case), Lot Number 23HME689; REF DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case), Lot Number 23GBA730; REF DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case), Lot Number 23HBG731; REF DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case), Lot Number 23HBT208; REF DYNJ57527C: UDI/DI 10195327243470 (each), 40195327243471 (case), Lot Number 23IBG463; REF DYNJ58257G: UDI/DI 10193489968644 (each), 40193489968645 (case), Lot Number 23KMI230; REF DYNJ58257G: UDI/DI 10193489968644 (each), 40193489968645 (case), Lot Number 24BME250; REF DYNJ58257G: UDI/DI 10193489968644 (each), 40193489968645 (case), Lot Number 24DME657; REF DYNJ58668D: UDI/DI 10195327529857 (each), 40195327529858 (case), Lot Number 23LMB473; REF DYNJ58668D: UDI/DI 10195327529857 (each), 40195327529858 (case), Lot Number 24AMH995; REF DYNJ58668D: UDI/DI 10195327529857 (each), 40195327529858 (case), Lot Number 24EMA379; REF DYNJ66495A: UDI/DI 10195327247584 (each), 40195327247585 (case), Lot Number 23DMG612; REF DYNJ66495A: UDI/DI 10195327247584 (each), 40195327247585 (case), Lot Number 23JMD696; REF DYNJ67968B: UDI/DI 10195327418649 (each), 40195327418640 (case), Lot Number 23IMG461; REF DYNJ67968B: UDI/DI 10195327418649 (each), 40195327418640 (case), Lot Number 24BMC283; REF DYNJ68464A: UDI/DI 10195327261665 (each), 40195327261666 (case), Lot Number 23LBN305; REF DYNJ68464A: UDI/DI 10195327261665 (each), 40195327261666 (case), Lot Number 24CBE964; REF DYNJ68464B: UDI/DI 10195327666224 (each), 40195327666225 (case), Lot Number 24DBP960; REF DYNJ83856: UDI/DI 10195327318253 (each), 40195327318254 (case), Lot Number 23GBV076; REF DYNJ83856A: UDI/DI 10195327520830 (each), 40195327520831 (case), Lot Number 23LBD001; REF DYNJ83856B: UDI/DI 10195327600648 (each), 40195327600649 (case), Lot Number 24CBA468; REF DYNJ83856B: UDI/DI 10195327600648 (each), 40195327600649 (case), Lot Number 24CBJ818; REF DYNJ83856B: UDI/DI 10195327600648 (each), 40195327600649 (case), Lot Number 24EBC307; REF DYNJ84332A: UDI/DI 10198459022432 (each), 40198459022433 (case), Lot Number 24EMI031; REF DYNJ85111: UDI/DI 10195327460808 (each), 40195327460809 (case), Lot Number 23JBC629; REF DYNJ900294L: UDI/DI 10195327554071 (each), 40195327554072 (case), Lot Number 24CBI707; REF DYNJ900294L: UDI/DI 1019…
UPC codes
10195327351533, 40195327351534, 10193489288872, 40193489288873, 10195327418717, 40195327418718, 10195327329136, 40195327329137, 10195327586683, 40195327586684, 10195327208127, 40195327208128, 10195327422523, 40195327422524, 10195327325220, 40195327325221, 10195327243470, 40195327243471, 10193489968644, 40193489968645

Products covered by this recall

MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M; 6) AUGMENTATION #87-RF, REF DYNJ27319V; 7) BREAST AUGMENTATION PACK, REF DYNJ33977M; 8) BREAST RECONSTRUCTION-HOULE, REF DYNJ44852M; 9) BREAST PACK, REF DYNJ57527C; 10) TRANSGENDER MASTECTOMY 2, REF DYNJ58257G; 11) ISS MAJOR BREAST PACK, REF DYNJ58668D; 12) CHEST/BREAST PACK, REF DYNJ66495A; 13) MAJOR PLASTICS PACK, REF DYNJ67968B; 14) BREAST PACK, REF DYNJ68464A; 15) BREAST PACK, REF DYNJ68464B; 16) PLASTIC PACK, REF DYNJ83856; 17) PLASTIC PACK, REF DYNJ83856A; 18) PLASTIC PACK, REF DYNJ83856B; 19) BREAST PACK, REF DYNJ84332A; 20) ACH PLASTICS BREAST PK-LF, REF DYNJ85111; 21) BREAST-CHEST, REF DYNJ900294L; 22) PLASTICS MASTECTOMY, REF DYNJ904966C; 23) BREAST PLASTIC, REF DYNJ906638B; 24) BREAST-CHEST, REF DYNJ907141B; 25) BREAST RECONSTRUCTION PACK, REF DYNJ907791B; 26) BREAST RECONSTRUCTION PACK, REF DYNJ907791D; 27) BREAST HERNIA, REF DYNJ908058A; 28) CHEST BREAST KIT, REF DYNJ909203A; 29) PLASTIC, REF DYNJ909410; 30) PLASTIC, REF DYNJ910440; 31) BREAST -LF, REF DYNJ9426113N; 32) GP-PLASTIC BREAST ABD PACK-LF, REF PHS397064007D.

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.

  • 10195327351533
  • 40195327351534
  • 10193489288872
  • 40193489288873
  • 10195327418717
  • 40195327418718
  • 10195327329136
  • 40195327329137
  • 10195327586683
  • 40195327586684
  • 10195327208127
  • 40195327208128
  • 10195327422523
  • 40195327422524
  • 10195327325220
  • 40195327325221
  • 10195327243470
  • 40195327243471
  • 10193489968644
  • 40193489968645

Lot or batch code

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

  • 23FBP157
  • 23GBM569
  • 23LBN523
  • 24BBA266
  • 24CBS676
  • 24EBM454
  • 23HMA639
  • 23HMF507
  • 23GMI327
  • 23JMC006
  • 23LMA065
  • 23LMC367
  • 24DMF699
  • 24EMA236
  • 23GBI654
  • 23GBJ925
  • 23HBZ090
  • 23HBB046
  • 23HME689
  • 23GBA730

Model or item number

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

  • CDS983639K
  • CDS984267J
  • DYNJ00264M
  • DYNJ0428947L
  • DYNJ0428947M
  • DYNJ27319V
  • DYNJ33977M
  • DYNJ44852M
  • DYNJ57527C
  • DYNJ58257G
  • DYNJ58668D
  • DYNJ66495A
  • DYNJ67968B
  • DYNJ68464A
  • DYNJ68464B
  • DYNJ83856
  • DYNJ83856A
  • DYNJ83856B
  • DYNJ84332A
  • DYNJ85111

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 — This product can overheat or catch fire, which is why the instruction is to unplug and stop using it rather than to keep an eye on 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.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.
  • If you bought it from a retailer rather than the brand, try both. Target, Walmart and Amazon often refund recalled goods from the order history.
  • If the company stops responding, escalate to the CPSC. Firms under a recall order have reporting duties to the agency.

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 10195327351533, 40195327351534, 10193489288872; lot code 23FBP157, 23GBM569, 23LBN523; model number CDS983639K, CDS984267J, DYNJ00264M. 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?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

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