Reported Jan 21, 2026 · Ongoing
Medline medical procedure convenience kits labeled as
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
230 of 230 products
| Model / number | Barcodes | Product as published |
|---|---|---|
CDS980523M | 1019532750891340195327508914 | UDI/DI 10195327508913 (EA) 40195327508914 (CS), Lot number 25FBF036 |
CDS980523M | 1019532750891340195327508914 | UDI/DI 10195327508913 (EA) 40195327508914 (CS), Lot number 25DBB218 |
CDS980647K | 1019532750892040195327508921 | UDI/DI 10195327508920 (EA) 40195327508921 (CS), Lot number 25DBP829 |
CDS980647K | 1019532750892040195327508921 | UDI/DI 10195327508920 (EA) 40195327508921 (CS), Lot number 25CBI860 |
CDS980864Q | 1019845912193740198459121938 | UDI/DI 10198459121937 (EA) 40198459121938 (CS), Lot number 25EMC533 |
CDS981583U | 1019532720976640195327209767 | UDI/DI 10195327209766 (EA) 40195327209767 (CS), Lot number 25CBC570 |
CDS981583V | 1019845931139040198459311391 | UDI/DI 10198459311390 (EA) 40198459311391 (CS), Lot number 25FBK816 |
CDS981583V | 1019845931139040198459311391 | UDI/DI 10198459311390 (EA) 40198459311391 (CS), Lot number 25EBS462 |
CDS981826K | 1019845922480540198459224806 | UDI/DI 10198459224805 (EA) 40198459224806 (CS), Lot number 25FBH633 |
CDS981826K | 1019845922480540198459224806 | UDI/DI 10198459224805 (EA) 40198459224806 (CS), Lot number 25BBU420 |
CDS982377K | 1019845922903940198459229030 | UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25DMI839 |
CDS982377K | 1019845922903940198459229030 | UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25DMF861 |
CDS982377K | 1019845922903940198459229030 | UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25CMC823 |
CDS982779N | 1019532764771140195327647712 | UDI/DI 10195327647711 (EA) 40195327647712 (CS), Lot number 25EBF365 |
CDS982779N | 1019532764771140195327647712 | UDI/DI 10195327647711 (EA) 40195327647712 (CS), Lot number 25CBM352 |
CDS982780V | 1019532764772840195327647729 | UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25EBI642 |
CDS982780V | 1019532764772840195327647729 | UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25DBP916 |
CDS982780V | 1019532764772840195327647729 | UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25CBT429 |
CDS982857K | 1019348992786340193489927864 | UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25FBR222 |
CDS982857K | 1019348992786340193489927864 | UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25EBJ713 |
- Amount recalled
- 12584 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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