Z-1089-2026 Class II Ongoing

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, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927.

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.

REF CDS980754T: UDI/DI 10198459121814 (EA) 40198459121815 (CS), Lot Number 25EMD795; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBR237; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBP591; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25DBM353; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25CBL184; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25BBL633; REF CDS985344F: UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25FBK918; REF CDS985344F: UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25CBJ496; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25FBF371; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25EBK493; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25DBH895; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25DBC272; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBU642; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBJ298; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25BBU206; REF DYNJ901281I: UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25FBA261; REF DYNJ901281I: UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25CBN230; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25FDB398; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25DDA191; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25BDB095; REF DYNJ902030J: UDI/DI 10195327391249 (EA) 40195327391240 (CS), Lot Number 25DBJ371; REF DYNJ905274D: UDI/DI 10195327393014 (EA) 40195327393015 (CS), Lot Number 25BBS130; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25FBJ689; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25EBP700; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25DBG283; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBJ430; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBC561; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBK650; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBE453; REF DYNJ910634: UDI/DI 10198459050398 (EA) 40198459050399 (CS), Lot Number 25CBS527; REF DYNJ910927: UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25FMC511; REF DYNJ910927: UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25CMJ281.