The Recall Desk

Manufacturer

Stryker Corporation

88 recalls in our database name Stryker Corporation as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 88

  • ModerateFDA (Devices)·Z-2166-2026·2026-05-20

    Thermedx FluidSmart Urology Tube Set recalled for nonconforming products

    Stryker Corporation is recalling the Thermedx FluidSmart Urology Tube Set (Catalog No. LL0006) due to nonconforming products that were inadvertently distributed. The affected tube sets were distributed nationwide in Georgia.

    Product
    Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warmi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1427-2026·2026-02-25

    Stryker MOLLI 2 Surgical Markers Recalled for Dislodgement Risk

    Stryker Corporation recalls MOLLI 2 surgical markers due to dislodgement risk when magnetized surgical tools are used during procedures. The company is updating product labeling to address the issue.

    Product
    MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 008500241951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0601-2026·2025-12-03

    NICO BrainPath Surgical Instruments Recalled for Undisclosed Latex in Packaging

    Stryker is recalling NICO BrainPath neurosurgical instruments because packaging tape contains latex despite products being labeled as latex-free, which could cause allergic reactions in sensitive individuals.

    Product
    NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2026·2025-12-03

    NICO Myriad Surgical Handpieces Recalled for Latex Contamination in Packaging

    Stryker has recalled NICO Myriad surgical handpieces because packaging tape contains latex despite products being labeled latex-free. Latex exposure could cause allergic reactions in sensitive patients.

    Product
    NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010 17x31.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0600-2026·2025-12-03

    Medical Device Illumination Pack Recalled for Undisclosed Latex in Packaging

    Stryker Corporation is recalling the NICO Myriad Illumination Pack because tape used in packaging contains latex despite the product being labeled as latex-free. Latex may cause allergic reactions in sensitive individuals.

    Product
    NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2025·2025-08-13

    Stryker SmartPump Tourniquet cuff flange may detach during surgery

    Stryker SmartPump Tourniquet cuff flanges may detach during use, causing potential hemorrhage and cardiovascular collapse. Distributed nationwide and internationally.

    Product
    Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2025·2025-07-30

    Stryker StrykeFlow Suction Irrigator Recalled for Potential Liquid Leakage

    Stryker is recalling its StrykeFlow suction/irrigator device due to potential irrigation solution leakage into the handpiece and battery pack, which could cause device malfunction.

    Product
    Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2025·2025-07-30

    Stryker StrykeFlow Disposable Suction/Irrigator Malfunction Recall

    Stryker is recalling StrykeFlow disposable suction/irrigators because irrigation solution may leak into the handpiece and battery pack, causing potential device malfunction.

    Product
    Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2025·2025-04-09

    Nasopore Nasal Dressing Recall Due to Breached Sterile Packaging

    Stryker Corporation is recalling Nasopore nasal dressings due to defects in blister seals that may compromise sterility. Affected products may have bubbles on the seal, indicating the sterile barrier has been breached.

    Product
    Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2025·2025-04-09

    Hemopore nasal wound dressing packaging seal defect may compromise sterility

    Stryker Corporation is recalling 182,344 units of Hemopore nasal/sinus wound dressing due to potential packaging seal defects that could compromise sterility. A bubble on the blister seal may indicate the sterile barrier has been breached.

    Product
    Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2025·2025-04-09

    Nasopore Standard Nasal Dressing Recalled Due to Sterility Seal Defects

    Stryker is recalling 182,344 units of Nasopore Standard nasal dressings nationwide due to potential bubbles in blister seals that may breach the sterility barrier and increase contamination risk.

    Product
    Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2025·2025-04-09

    Stryker nasal wound dressing recalled for defective sterile packaging seal

    Stryker Corporation is recalling 182,344 units of Hemopore 2PK nasal/sinus wound dressing due to potential bubbles in blister seals that indicate sterility breach. Affected lot numbers are 2024020221, 2024051720, and 2024082321.

    Product
    Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1474-2025·2025-04-09

    Nasopore nasal dressing recall: compromised sterile barrier seals

    Stryker recalls Nasopore 4cm fragmentable nasal dressings due to potential blister seal damage that compromises the sterile barrier. Nationwide distribution affected.

    Product
    Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2025·2025-04-09

    Nasopore nasal dressing may have compromised sterile packaging

    Stryker is recalling Nasopore Standard 4cm nasal dressings because the blister seals may develop bubbles, potentially compromising the sterility barrier. Affected units should not be used.

    Product
    Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2025·2025-04-09

    Nasopore FD nasal dressing recalled for potential sterile barrier breach

    Stryker Corporation is recalling 182,344 units of Nasopore FD nasal dressing nationwide due to potentially breached sterile seals that may allow product contamination.

    Product
    Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2025·2025-04-09

    Stryker Nasopore Nasal Dressing Recalled for Compromised Sterility Seals

    Stryker's Nasopore 8cm nasal dressing is being recalled because packaging seals may have bubbles indicating the sterility barrier has been breached. The recall affects 182,344 units distributed nationwide.

    Product
    Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2025·2025-04-09

    Nasopore Nasal Dressings Recalled Due to Breached Sterility Seals

    Stryker Corporation is recalling Nasopore nasal dressings due to potential breaches in packaging sterility seals that could compromise product sterilization. Approximately 182,344 units have been distributed nationwide.

    Product
    Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1479-2025·2025-04-09

    Nasal dressing recall: potential sterile barrier breach from seal defect

    Stryker is recalling over 182,000 Nasopore nasal dressings due to potential bubbles in the blister seal that could compromise the sterile barrier. The affected units were distributed nationwide.

    Product
    Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1469-2025·2025-04-09

    Otopore Outer Ear Dressings Recalled for Compromised Sterile Packaging Seals

    Stryker Corporation is recalling 182,344 Otopore Cylinder Standard outer ear dressings due to potential defects in blister seals that may compromise sterility. Bubbles in packaging seals indicate the sterile barrier is breached.

    Product
    Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1480-2025·2025-04-09

    Nasopore Nasal Dressing Recall Due to Compromised Sterile Packaging Seals

    Stryker Corporation is recalling Nasopore nasal dressings due to potentially compromised sterile packaging seals. Affected units totaling 182,344 may have lost sterility, posing a contamination risk.

    Product
    Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2025·2025-04-09

    Otopore Cylinder Wound Dressing Recalled for Potential Sterility Seal Defect

    Stryker Corporation recalls Otopore Cylinder outer ear wound dressing due to potential bubbles in blister seals that may breach the sterile barrier. Affected units were distributed nationwide.

    Product
    Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1475-2025·2025-04-09

    Otopore Square Outer Ear Wound Dressing Recall for Sterility Seal Defect

    Stryker Corporation is recalling Otopore Square outer ear wound dressings nationwide because sterile packaging seals may develop bubbles, indicating a potential breach of the sterile barrier. Consumers should stop using affected units and contact their healthcare provider.

    Product
    Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2025·2025-03-19

    Stryker CinchLock anchor recalled due to pullwire breakage

    Stryker is recalling its CinchLock Flex Knotless Anchor due to an increase in pullwire breakage complaints. The broken pullwire may remain in the implant body after deployment.

    Product
    Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1139-2025·2025-02-19

    Stryker Precision Thin surgical blade attachments recalled for specification defect

    Stryker is recalling Precision Thin surgical blade attachments that may be out of specification and fail to fit securely into compatible handpieces. The defect affects 238 units distributed worldwide, with no reported injuries.

    Product
    stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1138-2025·2025-02-19

    Stryker Precision Thin Blade Attachments Recalled for Measurement Failure

    Stryker Corporation is recalling 622 units of Precision Thin blade attachments that may be out of measurement specifications, preventing them from fitting securely into compatible handpieces.

    Product
    stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
    Category
    Medical Device
    Distribution
    0 states