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.

76–100 of 161

  • ModerateFDA (Devices)·Z-1563-2015·2015-05-13

    Stryker Recalls Wound Drains Due to Potential Sterility Breach

    Stryker Instruments is voluntarily recalling specific wound drain products because the packaging may have a sterility breach.

    Product
    3/16 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2015·2015-05-13

    Stryker Recalls Curved Trocar Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling 1/8 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.

    Product
    1/8 in. Curved 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
  • ModerateFDA (Devices)·Z-1570-2015·2015-05-13

    Stryker Recalls Curved Trocar Wound Drains for Sterility Breach

    Stryker is voluntarily recalling 3/16 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.

    Product
    3/16 in. Curved 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1572-2015·2015-05-13

    Stryker Recalls Curved Trocar Wound Drains for Sterility Breach

    Stryker Instruments is voluntarily recalling 1/4 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.

    Product
    1/4 in. Curved 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
  • ModerateFDA (Devices)·Z-1566-2015·2015-05-13

    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
    1/4 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
  • LowFDA (Devices)·Z-1587-2015·2015-05-13

    Stryker Universal Battery Charger Recalled for Software Data Transmission Issue

    Stryker is recalling 223 Universal Battery Chargers because they are not transmitting usage data to the Stryker Cloud as designed. A software correction is being initiated.

    Product
    Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1066-2015·2015-02-18

    Stryker Recalls System 6 Aseptic Housings Due to Weld Defect

    Stryker is recalling 399 System 6 Aseptic Housings because a failed test revealed a lack of a continual weld. Customers are instructed to return the product to Stryker.

    Product
    System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1077-2015·2015-02-18

    Stryker Flyte Toga Recall Due to Incorrect Expiration Date Labeling

    Stryker is recalling Flyte Togas with an incorrect expiration date. The label reads 2412-12-01 instead of 2014-12-01.

    Product
    Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classif
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0986-2015·2015-01-21

    Stryker Recalls SurgiCounter Charging Cradles Due to Charging Defects

    Stryker is recalling 3,625 SurgiCounter Charging Cradles because they may fail to charge the scanner or download data after surgical procedures.

    Product
    The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0173-2015·2014-11-12

    Stryker SmartLife Aseptic Housings Recalled for Welding Defect

    Stryker is recalling SmartLife Small Aseptic Housings because the top section may separate from the bottom due to insufficient welding.

    Product
    Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Hand
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0172-2015·2014-11-12

    Stryker SmartLife Aseptic Housings Recalled for Welding Defect

    Stryker is recalling SmartLife Large Aseptic Housings because the top section may separate from the bottom due to insufficient welding.

    Product
    Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Hand
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2014·2014-08-13

    Stryker Recalls Sonopet Ultrasonic Surgical Systems Due to Irrigation Defect

    Stryker is recalling 2,460 Sonopet Ultrasonic Surgical Systems because insufficient irrigation to the tip can potentially lead to excessive heat.

    Product
    Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1756-2014·2014-06-18

    Stryker 3.0mm Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 285 sterile 3.0mm Round Fluted Bur Aggressive devices due to missing or partial notches. The defect may affect the device's compatibility with Elite Attachments.

    Product
    Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1760-2014·2014-06-18

    Stryker Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 301 sterile 6.0mm Round Fluted Bur Aggressive devices because some units have missing or partial notches.

    Product
    Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1769-2014·2014-06-18

    Stryker 5.0mm Acorn Bur Recalled for Missing Notches

    Stryker is recalling 71 units of 5.0mm Acorn Bur sterile cutting accessories due to missing or partial notches.

    Product
    Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1758-2014·2014-06-18

    Stryker 5.0mm Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 1,537 sterile 5.0mm Round Fluted Bur Aggressive devices because some units have missing, partial, or no notches.

    Product
    Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1778-2014·2014-06-18

    Stryker Precision Neuro Drill Recall Due to Missing Notches

    Stryker is recalling 6,481 Precision Neuro Drills because some cutting accessories may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical app
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1777-2014·2014-06-18

    Stryker Neuro Drill Recall Due to Missing Notches on Cutting Accessories

    Stryker is recalling 497 sterile neuro drills because some cutting accessories may have missing or partial notches, which could affect their use with Elite attachments.

    Product
    Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1762-2014·2014-06-18

    Stryker Zyphr Elite Round Fluted Bur Recall for Missing Notches

    Stryker is recalling 39 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1751-2014·2014-06-18

    Stryker 2.0mm Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 252 sterile 2.0mm Round Fluted Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.

    Product
    Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1764-2014·2014-06-18

    Stryker Recalls Zyphr Elite Round Fluted Bur Due to Missing Notches

    Stryker is recalling 107 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1765-2014·2014-06-18

    Stryker Recalls Zyphr Elite Round Fluted Bur Due to Missing Notches

    Stryker is recalling four sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, potentially affecting their use with Elite Attachments.

    Product
    Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1780-2014·2014-06-18

    Stryker Neuro Drill Accessories Recalled for Missing Notches

    Stryker is recalling 916 sterile neuro drill cutting accessories due to missing or partial notches that may affect device performance.

    Product
    Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1779-2014·2014-06-18

    Stryker 5.0mm Barrel Bur Recall for Missing Notches

    Stryker is recalling 5.0mm Barrel Bur devices because some units have missing or partial notches, which may affect their use with Elite Attachments.

    Product
    Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1749-2014·2014-06-18

    Stryker 0.5mm Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 27 sterile 0.5mm Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications incl
    Category
    Medical Device
    Distribution
    Distributed nationwide