[pending] Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC G
Pending LLM rewrite. Source: FDA_DEVICE Z-1088-2026.
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) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K
- 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 CDS980523M: UDI/DI 10195327508913 (EA) 40195327508914 (CS)
- Lot number 25FBF036
- Lot number 25DBB218
- REF CDS980647K: UDI/DI 10195327508920 (EA) 40195327508921 (CS)
- Lot number 25DBP829
- Lot number 25CBI860
- REF CDS980864Q: UDI/DI 10198459121937 (EA) 40198459121938 (CS)
- Lot number 25EMC533
- REF CDS981583U: UDI/DI 10195327209766 (EA) 40195327209767 (CS)
- Lot number 25CBC570
- REF CDS981583V: UDI/DI 10198459311390 (EA) 40198459311391 (CS)
- Lot number 25FBK816
- Lot number 25EBS462
- REF CDS981826K: UDI/DI 10198459224805 (EA) 40198459224806 (CS)
- Lot number 25FBH633
- Lot number 25BBU420
- REF CDS982377K: UDI/DI 10198459229039 (EA) 40198459229030 (CS)
- Lot number 25DMI839
- Lot number 25DMF861
- Lot number 25CMC823
Distribution
Distributed nationwide across the United States.
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