Stryker Corporation
FDA Regulatory Profile
Stryker Corporation appears in FDA public data with 110 recalls, 81 510(k) clearances, 19 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2282-2026, Class II) was initiated on May 6, 2026. Its most recent 510(k) clearance was granted on August 18, 2023.
Summary
- Total Recalls
- 110
- 510(k) Clearances
- 81
- Inspections
- 19
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2282-2026 | Class II | Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Managem | May 6, 2026 |
| Z-2166-2026 | Class II | Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube | April 9, 2026 |
| Z-1427-2026 | Class II | MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker | January 21, 2026 |
| Z-0600-2026 | Class II | NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN | October 31, 2025 |
| Z-0599-2026 | Class II | NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; | October 31, 2025 |
| Z-0601-2026 | Class II | NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN- | October 31, 2025 |
| Z-2277-2025 | Class II | Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-0 | July 2, 2025 |
| Z-2170-2025 | Class II | Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip | June 18, 2025 |
| Z-2171-2025 | Class II | Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip | June 18, 2025 |
| Z-1479-2025 | Class II | Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plu | February 25, 2025 |
| Z-1472-2025 | Class II | Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number | February 25, 2025 |
| Z-1481-2025 | Class II | Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm | February 25, 2025 |
| Z-1482-2025 | Class II | Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S | February 25, 2025 |
| Z-1473-2025 | Class II | Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number | February 25, 2025 |
| Z-1478-2025 | Class II | Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plu | February 25, 2025 |
| Z-1469-2025 | Class II | Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL | February 25, 2025 |
| Z-1475-2025 | Class II | Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5 | February 25, 2025 |
| Z-1470-2025 | Class II | Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL | February 25, 2025 |
| Z-1471-2025 | Class II | Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL | February 25, 2025 |
| Z-1477-2025 | Class II | Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL | February 25, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232157 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and | August 18, 2023 |
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker | February 16, 2023 |
| K223770 | Sonopet 1Q 3 7cm 1Q Large | February 16, 2023 |
| K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Pla | October 19, 2022 |
| K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device | September 16, 2022 |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigat | July 12, 2022 |
| K213824 | Sonopet iQ Ultrasonic Aspirator System | February 3, 2022 |
| K212055 | Connected OR Hub with Device and Voice Control | December 16, 2021 |
| K210377 | Stryker iBur hubs and cutting accessories | June 30, 2021 |
| K202964 | iBed Wireless with iBed Mobile | June 18, 2021 |
| K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 | June 9, 2021 |
| K202393 | SpineJack Expansion Kit | October 20, 2020 |
| K202609 | Instrument Clamps Electromagnetic | October 9, 2020 |
| K201585 | Monterey AL Interbody System | August 10, 2020 |
| K200613 | Tritanium® X TL Expandable Curved Posterior Lumbar Cage | April 15, 2020 |
| K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System | March 31, 2020 |
| K200493 | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered | March 21, 2020 |
| K191049 | Stryker MIS and Footed Attachments | June 18, 2019 |
| K190070 | Sonopet iQ Ultrasonic Aspirator System | April 11, 2019 |
| K183196 | Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscop | February 14, 2019 |