Stryker Corporation

FDA Regulatory Profile

Summary

Total Recalls
110
510(k) Clearances
81
Inspections
19
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2282-2026Class IINeptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste ManagemMay 6, 2026
Z-2166-2026Class IIThermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube April 9, 2026
Z-1427-2026Class IIMOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI MarkerJanuary 21, 2026
Z-0601-2026Class IINICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-October 31, 2025
Z-0599-2026Class IINICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; October 31, 2025
Z-0600-2026Class IINICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NNOctober 31, 2025
Z-2277-2025Class IIStryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-0July 2, 2025
Z-2170-2025Class IIStryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable TipJune 18, 2025
Z-2171-2025Class IIStryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable TipJune 18, 2025
Z-1478-2025Class IINasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte pluFebruary 25, 2025
Z-1476-2025Class IINasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITLFebruary 25, 2025
Z-1475-2025Class IIOtopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5February 25, 2025
Z-1471-2025Class IINasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITLFebruary 25, 2025
Z-1472-2025Class IIOtopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog NumberFebruary 25, 2025
Z-1474-2025Class IINasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number February 25, 2025
Z-1480-2025Class IINasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cmFebruary 25, 2025
Z-1473-2025Class IINasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number February 25, 2025
Z-1479-2025Class IINasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte pluFebruary 25, 2025
Z-1470-2025Class IINasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITLFebruary 25, 2025
Z-1477-2025Class IIHemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL February 25, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K232157Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and August 18, 2023
K223770Sonopet 1Q 3 7cm 1Q LargeFebruary 16, 2023
K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope TrackerFebruary 16, 2023
K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical PlaOctober 19, 2022
K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceSeptember 16, 2022
K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic NavigatJuly 12, 2022
K213824Sonopet iQ Ultrasonic Aspirator SystemFebruary 3, 2022
K212055Connected OR Hub with Device and Voice ControlDecember 16, 2021
K210377Stryker iBur hubs and cutting accessoriesJune 30, 2021
K202964iBed Wireless with iBed MobileJune 18, 2021
K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000June 9, 2021
K202393SpineJack Expansion KitOctober 20, 2020
K202609Instrument Clamps ElectromagneticOctober 9, 2020
K201585Monterey AL Interbody SystemAugust 10, 2020
K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageApril 15, 2020
K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemMarch 31, 2020
K200493Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered March 21, 2020
K191049Stryker MIS and Footed AttachmentsJune 18, 2019
K190070Sonopet iQ Ultrasonic Aspirator SystemApril 11, 2019
K183196Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and FluoroscopFebruary 14, 2019