Stryker Instruments Div. of Stryker Corporation

FDA Regulatory Profile

Summary

Total Recalls
161 (4 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1452-2022Class IISurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counJune 15, 2022
Z-0431-2021Class IIStryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessOctober 16, 2020
Z-1807-2020Class IINeptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP March 26, 2020
Z-1402-2022Class IITriton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canistJanuary 22, 2020
Z-1097-2020Class IISafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencilJanuary 13, 2020
Z-1098-2020Class IITelescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that January 13, 2020
Z-1099-2020Class IITelescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 iJanuary 13, 2020
Z-0593-2020Class IIColor Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) QuicNovember 6, 2019
Z-0592-2020Class IIColor Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) QuNovember 6, 2019
Z-0023-2020Class IIC2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve MonitoJuly 31, 2019
Z-0024-2020Class IIC2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve MonitoJuly 31, 2019
Z-1215-2019Class IIPerformance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy March 19, 2019
Z-1394-2022Class IIITriton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6December 4, 2018
Z-1501-2018Class IIT4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garmentFebruary 23, 2018
Z-1500-2018Class IIT4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garmentFebruary 23, 2018
Z-1505-2018Class IIT4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garmentFebruary 23, 2018
Z-1506-2018Class IIT4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garmentFebruary 23, 2018
Z-1508-2018Class IIT4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garmentFebruary 23, 2018
Z-1502-2018Class IIT4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garmentFebruary 23, 2018
Z-1507-2018Class IIT5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal prFebruary 23, 2018