Stryker Instruments Div. Of Stryker Corporation

FDA Regulatory Profile

Stryker Instruments Div. Of Stryker Corporation has 161 FDA recalls (4 Class I), 0 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest recall
Z-1452-2022 · Class II · Jun 15, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls161 (4 Class I)Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
Z-1452-2022Class IISurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for…Jun 15, 2022
Z-0431-2021Class IIStryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting…Oct 16, 2020
Z-1807-2020Class IINeptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP…Mar 26, 2020
Z-1402-2022Class IITriton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L…Jan 22, 2020
Z-1098-2020Class IITelescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that…Jan 13, 2020
Z-1097-2020Class IISafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil…Jan 13, 2020
Z-1099-2020Class IITelescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75…Jan 13, 2020
Z-0592-2020Class IIColor Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port)…Nov 6, 2019
Z-0593-2020Class IIColor Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port)…Nov 6, 2019
Z-0023-2020Class IIC2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve…Jul 31, 2019
Z-0024-2020Class IIC2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve…Jul 31, 2019
Z-1215-2019Class IIPerformance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy…Mar 19, 2019
Z-1394-2022Class IIITriton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6Dec 4, 2018
Z-1503-2018Class IIT4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garmentFeb 23, 2018
Z-1500-2018Class IIT4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garmentFeb 23, 2018
Z-1505-2018Class IIT4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garmentFeb 23, 2018
Z-1502-2018Class IIT4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garmentFeb 23, 2018
Z-1506-2018Class IIT4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garmentFeb 23, 2018
Z-1507-2018Class IIT5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal…Feb 23, 2018
Z-1510-2018Class IIT5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal…Feb 23, 2018

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.