Class II U.S. Food and Drug Administration

Medline medical procedure convenience kits labeled as: 1) Lavh recall: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators

Recall published 9 months ago

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

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 kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

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-1089-2026
Published
January 21, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
1457 units
Distribution
Nationwide
Made in
United States
Lot / code info
REF CDS980754T: UDI/DI 10198459121814 (EA) 40198459121815 (CS), Lot Number 25EMD795; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBR237; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBP591; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25DBM353; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25CBL184; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25BBL633; REF CDS985344F: UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25FBK918; REF CDS985344F: UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25CBJ496; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25FBF371; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25EBK493; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25DBH895; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25DBC272; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBU642; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBJ298; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25BBU206; REF DYNJ901281I: UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25FBA261; REF DYNJ901281I: UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25CBN230; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25FDB398; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25DDA191; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25BDB095; REF DYNJ902030J: UDI/DI 10195327391249 (EA) 40195327391240 (CS), Lot Number 25DBJ371; REF DYNJ905274D: UDI/DI 10195327393014 (EA) 40195327393015 (CS), Lot Number 25BBS130; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25FBJ689; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25EBP700; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25DBG283; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBJ430; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBC561; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBK650; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBE453; REF DYNJ910634: UDI/DI 10198459050398 (EA) 40198459050399 (CS), Lot Number 25CBS527; REF DYNJ910927: UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25FMC511; REF DYNJ910927: UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25CMJ281.
UPC codes
10198459121814, 40198459121815, 10195327306793, 40195327306794, 10195327312565, 40195327312566, 10198459043086, 40198459043087, 10195327464929, 40195327464920, 10195327699154, 40195327699155, 10198459231384, 40198459231385, 10195327391249, 40195327391240, 10195327393014, 40195327393015, 10198459202025, 40198459202026

Products covered by this recall

Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927.

Check your product

The notice names 54 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.

  • 10198459121814
  • 40198459121815
  • 10195327306793
  • 40195327306794
  • 10195327312565
  • 40195327312566
  • 10198459043086
  • 40198459043087
  • 10195327464929
  • 40195327464920
  • 10195327699154
  • 40195327699155
  • 10198459231384
  • 40198459231385
  • 10195327391249
  • 40195327391240
  • 10195327393014
  • 40195327393015
  • 10198459202025
  • 40198459202026

Lot or batch code

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

  • 25EMD795
  • 25EBR237
  • 25EBP591
  • 25DBM353
  • 25CBL184
  • 25BBL633
  • 25FBK918
  • 25CBJ496
  • 25FBF371
  • 25EBK493
  • 25DBH895
  • 25DBC272
  • 25CBU642
  • 25CBJ298
  • 25BBU206
  • 25FBA261
  • 25CBN230
  • 25FDB398
  • 25DDA191
  • 25BDB095

Model or item number

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

  • CDS980754T
  • CDS982662Q
  • CDS985344F
  • DYNJQ9041R
  • DYNJ900244I
  • DYNJ901281I
  • DYNJ901829T
  • DYNJ902030J
  • DYNJ905274D
  • DYNJ905485J
  • DYNJ906380C
  • DYNJ910634
  • DYNJ910927. — REF CDS980754T
  • DYNJ910927

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. 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.

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.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.

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 kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use. Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10198459121814, 40198459121815, 10195327306793; lot code 25EMD795, 25EBR237, 25EBP591; model number CDS980754T, CDS982662Q, CDS985344F. 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