Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC G
Pending LLM rewrite. Source: FDA_DEVICE Z-1088-2026.
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) 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.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22