The Recall Desk

Manufacturer

Stryker Instruments Div. of Stryker Corporation

161 recalls in our database name Stryker Instruments Div. of Stryker Corporation as the manufacturing or recalling firm.

What the numbers show

Total
161
Critical
4
Severe
11
Most recent
2022-07-27

Of the 161 recalls from Stryker Instruments Div. of Stryker Corporation we have scored against our rubric, 4 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (7%) are Severe.

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.

51–75 of 161

  • ModerateFDA (Devices)·Z-2536-2016·2016-08-24

    Stryker AutoPlex System Recalled Due to Piston Head Separation Risk

    Stryker is recalling AutoPlex System kits because the piston head may separate, blocking the valve and causing cement backflow toward the injector handle.

    Product
    Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2238-2016·2016-07-27

    Stryker 2.3mm Tapered Routers Recalled Due to Breakage Risk

    Stryker is recalling 2.3mm Tapered Routers because a variation in flute depth may cause breakage, posing a risk of injury to critical soft tissue.

    Product
    2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otology /Neurotology/ Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and St
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2205-2016·2016-07-20

    Stryker Recalls Specific Lots of Round Fluted Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of 6.0mm Round Fluted Burs due to potential tarnishing or corrosion that could cause inflammation requiring surgery.

    Product
    6.0mm Round Fluted Bur, Super Long
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2204-2016·2016-07-20

    Stryker Recalls 5.0mm Round Fluted Burs Due to Corrosion Risk

    Stryker Instruments is voluntarily recalling specific lots of 5.0mm Round Fluted Burs because tarnishing or corrosion may cause inflammation requiring surgery.

    Product
    5.0mm Round Fluted Bur, Super Long
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1939-2016·2016-06-15

    Stryker Recalls Maestro Air Motor Pneumatic Cranial Drill Units

    Stryker is recalling 189 Maestro Air Motor pneumatic cranial drill units because grease buildup may cause the orange grease to leak and contaminate surgical wounds.

    Product
    Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-1379-2016·2016-04-20

    Stryker SurgiCounter Scanner Recalled for Software Interaction Errors

    Stryker is recalling 286 SurgiCounter scanners because they may display error messages and fail to display software version numbers correctly in the SC360 application.

    Product
    SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1378-2016·2016-04-20

    Stryker Recalls Spetzler Claw Tips Due to Incorrect Packaging Assembly

    Stryker is recalling 140 Spetzler Claw Tips because they were packaged with the incorrect size Tip Sleeve Assembly, which may cause surgical delays.

    Product
    Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Claw" Tips are bone cutting tips which are a part of Strykers Neuro Spine Ear, Nose and Throat (ENT) Sonopet Portfolio. They are removable attachments inte
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1037-2016·2016-03-09

    Stryker AccuPlace Needle Guide Recalled for Sterility Breach Risk

    Stryker is recalling AccuPlace Straight Level Needle Guides because packaging defects may compromise sterility. The recall affects 5,800 units distributed nationwide.

    Product
    (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1040-2016·2016-03-09

    Stryker AccuPlace Drace Stereotaxic Needle Guide Recalled for Sterility Risk

    Stryker is recalling 5,800 AccuPlace Drace Stereotaxic Needle Guides due to a potential breach in sterility caused by packaging damage.

    Product
    50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1038-2016·2016-03-09

    Stryker AccuPlace Round Level Needle Guide Recalled for Sterility Breach Risk

    Stryker is recalling AccuPlace Round Level Needle Guides because packaging defects may compromise sterility. The recall affects 5,800 units distributed nationwide.

    Product
    (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1039-2016·2016-03-09

    Stryker AccuPlace Drace Stereotaxic Needle Guide Recalled for Packaging Sterility Risk

    Stryker is recalling AccuPlace Drace Stereotaxic Needle Guides because packaging defects may breach sterility. The recall covers 5,800 units distributed nationwide.

    Product
    50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2016·2015-12-23

    Stryker Guidewire Introducer Needles Recalled for Expiration Date Issues

    Stryker is recalling 120 units of Guidewire Introducer Needles shipped after expiration or with minimal time remaining due to infection risk.

    Product
    Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, she
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2524-2015·2015-09-09

    Stryker Neptune 2 Waste Management System Docking Station Recall

    Stryker is recalling Neptune 2 Waste Management System Docking Stations because a defective component may cause fluid leaks during use.

    Product
    Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Docker) is a component of the Neptune 2 Waste Management System. The Stryker Rover, another component of the system, is a mobile unit used to suc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2102-2015·2015-07-29

    Stryker SelectCore Biopsy Device Recalled for Stylet Ejection Risk

    Stryker is recalling 55 units of the SelectCore Variable Throw Biopsy Device because the stylet may eject during use.

    Product
    Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. Fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2099-2015·2015-07-29

    Stryker Neptune 2 Waste Management System Recalled for Diverter Valve Failures

    Stryker is recalling the Neptune 2 Waste Management System due to installation failures of the diverter valve assembly during docking.

    Product
    0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000, Neptune 2 Rover Ultra (230V) 0702-002-000ES, Neptune 2 Rover (230V) Spanish 0702-002-000FI, Neptune 2 Ultra Rover (230V) Finnish 0702-002-0
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2062-2015·2015-07-22

    Stryker Woundcare Replacement Kits Recalled for Potential Sterility Breach

    Stryker is recalling Woundcare Replacement Kits used for wound debridement due to a potential sterility breach in the packaging.

    Product
    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridemen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2015·2015-06-24

    Stryker Recalls Navigation System II-Cart Due to Weld Seam Defect

    Stryker is recalling 72 Navigation System II-Carts because a weld seam defect may cause the articulated arm joint to fail.

    Product
    Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2015·2015-06-03

    Stryker EliteCore Biopsy Device Recalled for Cannula Overthrow Risk

    Stryker is recalling EliteCore Full Core Biopsy Devices because the cannula may extend past its intended length.

    Product
    EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2015·2015-05-13

    Stryker Recalls Trocar Wound Drains Due to Potential Sterility Breach

    Stryker Instruments is voluntarily recalling specific trocar wound drains and ambulating bulbs because of a potential sterility breach in the packaging.

    Product
    3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2015·2015-05-13

    Stryker Recalls Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.

    Product
    3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1565-2015·2015-05-13

    Stryker Recalls Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.

    Product
    1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1569-2015·2015-05-13

    Stryker Recalls Wound Drains Due to Potential Sterility Breach

    Stryker Instruments is voluntarily recalling specific wound drain devices because of a potential sterility breach in the packaging.

    Product
    1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2015·2015-05-13

    Stryker Recalls Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.

    Product
    1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2015·2015-05-13

    Stryker Recalls Ambulating Bulbs Due to Potential Sterility Breach

    Stryker Instruments is voluntarily recalling Ambulating Bulbs used with wound drains because of a potential sterility breach in the packaging.

    Product
    Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1567-2015·2015-05-13

    Stryker Recalls Wound Drains and Ambulating Bulb for Sterility Breach

    Stryker Instruments is voluntarily recalling specific wound drain and ambulating bulb products due to a potential sterility breach in the packaging.

    Product
    1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection f
    Category
    Medical Device
    Distribution
    Distributed nationwide