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Stryker Corporation

98 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600 recall (Z-2862-2026)Stryker Corporation2026-08-03
STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620 recall (Z-2863-2026)Stryker Corporation2026-08-03
STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640 recall (Z-2864-2026)Stryker Corporation2026-08-03
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 recall (Z-2865-2026)Stryker Corporation2026-08-03
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540 recall (Z-2866-2026)Stryker Corporation2026-08-03
Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Was recall (Z-2282-2026)Stryker Corporation2026-06-01
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart recall (Z-2166-2026)Stryker Corporation2026-05-12
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLL recall (Z-1427-2026)Stryker Corporation2026-02-17
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; recall (Z-0599-2026)Stryker Corporation2025-11-26
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product N recall (Z-0600-2026)Stryker Corporation2025-11-26
NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; recall (Z-0601-2026)Stryker Corporation2025-11-26
Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / recall (Z-2277-2025)Stryker Corporation2025-08-07
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable recall (Z-2170-2025)Stryker Corporation2025-07-23
Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip recall (Z-2171-2025)Stryker Corporation2025-07-23
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-0 recall (Z-1469-2025)Stryker Corporation2025-03-28
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-0 recall (Z-1470-2025)Stryker Corporation2025-03-28
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-0 recall (Z-1471-2025)Stryker Corporation2025-03-28
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Cata recall (Z-1472-2025)Stryker Corporation2025-03-28
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catal recall (Z-1473-2025)Stryker Corporation2025-03-28
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catal recall (Z-1474-2025)Stryker Corporation2025-03-28
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalo recall (Z-1475-2025)Stryker Corporation2025-03-28
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL recall (Z-1476-2025)Stryker Corporation2025-03-28
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-0 recall (Z-1477-2025)Stryker Corporation2025-03-28
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore recall (Z-1478-2025)Stryker Corporation2025-03-28
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore recall (Z-1479-2025)Stryker Corporation2025-03-28
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Na recall (Z-1480-2025)Stryker Corporation2025-03-28
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Na recall (Z-1481-2025)Stryker Corporation2025-03-28
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S recall (Z-1482-2025)Stryker Corporation2025-03-28
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, recall (Z-1328-2025)Stryker Corporation2025-03-12
stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Bl recall (Z-1138-2025)Stryker Corporation2025-02-11
stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Bl recall (Z-1139-2025)Stryker Corporation2025-02-11
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bon recall (Z-0980-2025)Stryker Corporation2025-01-17
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during recall (Z-0981-2025)Stryker Corporation2025-01-17
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone ceme recall (Z-0982-2025)Stryker Corporation2025-01-17
100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPT recall (Z-0807-2025)Stryker Corporation2025-01-06
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for recall (Z-0365-2025)Stryker Corporation2024-11-13
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - D recall (Z-0366-2025)Stryker Corporation2024-11-13
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed recall (Z-0367-2025)Stryker Corporation2024-11-13
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - recall (Z-0368-2025)Stryker Corporation2024-11-13
Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Desig recall (Z-0369-2025)Stryker Corporation2024-11-13
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Des recall (Z-0370-2025)Stryker Corporation2024-11-13
1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticatin recall (Z-0063-2025)Stryker Corporation2024-10-11
Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following man recall (Z-2722-2024)Stryker Corporation2024-08-26
Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following man recall (Z-2723-2024)Stryker Corporation2024-08-26
Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manne recall (Z-2724-2024)Stryker Corporation2024-08-26
Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following mann recall (Z-2725-2024)Stryker Corporation2024-08-26
Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manne recall (Z-2726-2024)Stryker Corporation2024-08-26
Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the followi recall (Z-2727-2024)Stryker Corporation2024-08-26
Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the followi recall (Z-2728-2024)Stryker Corporation2024-08-26
Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following recall (Z-2729-2024)Stryker Corporation2024-08-26
Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following recall (Z-2730-2024)Stryker Corporation2024-08-26
Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the followin recall (Z-2731-2024)Stryker Corporation2024-08-26
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be wo recall (Z-2259-2024)Stryker Corporation2024-07-03
Curved, super elastic cement delivery needle that passes through the cannula in a straight recall (Z-2260-2024)Stryker Corporation2024-07-03
This product is a single use sterile device that is used to direct the lesion to the targe recall (Z-2261-2024)Stryker Corporation2024-07-03
Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2 recall (Z-0287-2024)Stryker Corporation2023-11-09
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number recall (Z-0239-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number recall (Z-0240-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number recall (Z-0241-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number recall (Z-0242-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number recall (Z-0243-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number recall (Z-0244-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number recall (Z-0245-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number recall (Z-0246-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number recall (Z-0247-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number recall (Z-0248-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number recall (Z-0249-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number recall (Z-0250-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number recall (Z-0251-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 678 recall (Z-0252-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 678 recall (Z-0253-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 678 recall (Z-0254-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 678 recall (Z-0255-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 678 recall (Z-0256-2024)Stryker Corporation2023-11-07
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 678 recall (Z-0257-2024)Stryker Corporation2023-11-07
Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462 recall (Z-2645-2023)Stryker Corporation2023-09-28
Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user t recall (Z-2596-2023)Stryker Corporation2023-09-19
Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Noz recall (Z-2597-2023)Stryker Corporation2023-09-19
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows th recall (Z-2598-2023)Stryker Corporation2023-09-19
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid B recall (Z-2599-2023)Stryker Corporation2023-09-19
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. M recall (Z-2600-2023)Stryker Corporation2023-09-19
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restricto recall (Z-2601-2023)Stryker Corporation2023-09-19
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restricto recall (Z-2602-2023)Stryker Corporation2023-09-19
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the recall (Z-2463-2023)Stryker Corporation2023-08-25
SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT recall (Z-1474-2023)Stryker Corporation2023-04-28
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Ca recall (Z-1339-2023)Stryker Corporation2023-04-04
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Ca recall (Z-1340-2023)Stryker Corporation2023-04-04
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Ca recall (Z-1341-2023)Stryker Corporation2023-04-04
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Ca recall (Z-1342-2023)Stryker Corporation2023-04-04
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK C recall (Z-1343-2023)Stryker Corporation2023-04-04
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Ca recall (Z-1344-2023)Stryker Corporation2023-04-04
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Numbe recall (Z-1184-2023)Stryker Corporation2023-02-27
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Numbe recall (Z-1185-2023)Stryker Corporation2023-02-27
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blo recall (Z-1186-2023)Stryker Corporation2023-02-27
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, na recall (Z-0728-2022)Stryker Corporation2022-03-07
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI recall (Z-1147-2020)Stryker Corporation2020-03-02
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 076133 recall (Z-1148-2020)Stryker Corporation2020-03-02
Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended recall (Z-1910-2016)Stryker Corporation2016-06-03

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Every clearance here is in the API, with alerts when new ones post.