FDA Device Recalls

Recalls / Firms / Stryker Corporation

Stryker Corporation

108 FDA device recalls on record.

DateClassProductReason
2026-01-21MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker U
2025-10-31NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025
2025-10-31NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002
2025-10-31NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-100
2025-07-02Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-0
2025-06-18Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
2025-06-18Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
2025-02-25Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm
2025-02-25Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number
2025-02-25Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
2025-02-25Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL
2025-02-25Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5
2025-02-25Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm
2025-02-25Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number
2025-02-25Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number
2025-02-25Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
2025-02-25Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plu
2025-02-25Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plu
2025-02-25Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
2025-02-25Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
2025-02-25Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
2025-01-29Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only M
2025-01-08stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
2025-01-08stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
2024-12-03100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 RO
2024-10-04Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for gener
2024-10-04Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for ge
2024-10-04Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general e
2024-10-04Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed fo
2024-10-04Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for
2024-10-04Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed f
2024-09-051.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping
2024-07-24Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drill
2024-07-24Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner:
2024-07-24Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: d
2024-07-24Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drill
2024-07-24Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner:
2024-07-24Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner:
2024-07-24Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drillin
2024-07-24Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner:
2024-07-24Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilli
2024-07-24Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drillin
2024-06-03Curved, super elastic cement delivery needle that passes through the cannula in a straight configura
2024-06-03This product is a single use sterile device that is used to direct the lesion to the targeted site.
2024-06-03The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with co
2023-09-13Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexStic
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-0
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-0
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-0
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-0
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-0
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-0
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-0
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-0
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-0
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-0
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-0
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-0
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-0
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010
2023-09-11Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015
2023-08-23Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
2023-08-07Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-
2023-08-07Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox.
2023-08-07Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox.
2023-08-07Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows
2023-08-07Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bon
2023-08-07Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allo
2023-08-07Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to
2023-07-10SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual pro
2023-06-28The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone
2023-06-28stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during
2023-06-28stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurge
2023-03-02SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF
2023-03-01Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog numb
2023-03-01Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog numb
2023-03-01Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog numb
2023-03-01Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog numb
2023-03-01Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog numb
2023-03-01Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog nu
2023-01-25Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 1202
2023-01-25Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 1201
2023-01-25Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
2022-01-141688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyng
2021-02-26Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI:
2020-01-07Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/208587
2020-01-07Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/1085
2019-09-12Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Steril
2019-09-12Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Steril
2019-07-19Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 076133274
2019-07-19Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818,
2019-04-23Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 59
2019-03-07Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to
2019-03-07Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insuffla
2019-03-07Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the
2018-01-25CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Produ
2017-12-213910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cann
2017-11-17STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tu
2017-11-17StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRR
2017-11-17ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
2017-11-17STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled
2016-05-04Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connec
2016-04-12CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLoc
2016-04-12CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock