Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GY
Pending LLM rewrite. Source: FDA_DEVICE Z-1089-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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 recalled product
- Product
- 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
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF CDS980754T: UDI/DI 10198459121814 (EA) 40198459121815 (CS)
- Lot Number 25EMD795
- REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS)
- Lot Number 25EBR237
- Lot Number 25EBP591
- Lot Number 25DBM353
- Lot Number 25CBL184
- Lot Number 25BBL633
- REF CDS985344F: UDI/DI 10195327312565 (EA) 40195327312566 (CS)
- Lot Number 25FBK918
- Lot Number 25CBJ496
- REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS)
- Lot Number 25FBF371
- Lot Number 25EBK493
- Lot Number 25DBH895
- REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS)
- Lot Number 25DBC272
- Lot Number 25CBU642
- Lot Number 25CBJ298
- Lot Number 25BBU206
Distribution
Distributed nationwide across the United States.
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