[pending] Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GY
Pending LLM rewrite. Source: FDA_DEVICE Z-1089-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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