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.

126–150 of 161

  • ModerateFDA (Devices)·Z-0630-2014·2014-01-15

    Stryker Color Cuff Tourniquet Cuffs Recalled for Incorrect Connector

    Stryker is recalling specific Color Cuff tourniquets because they may have the wrong connector, which can make the system inoperable.

    Product
    Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx only, STERILE
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0280-2014·2013-11-20

    Stryker Recalls Acetabular Pressurizers Due to Cracked Assemblies

    Stryker is recalling 87 boxes of Acetabular Pressurizers because cracked assemblies may release during cement application.

    Product
    Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-52
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0127-2014·2013-11-13

    Stryker Recalls Dekompressor Percutaneous Discectomy Probes Due to Fracture Risk

    Stryker is recalling Dekompressor Percutaneous Discectomy Probes because the auger or cannula may fracture if the device is manually bent, potentially requiring additional medical intervention.

    Product
    Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0092-2014·2013-11-06

    Stryker TPS Micro Driver Recalled for Silicone Potting Defect

    Stryker is recalling 67 TPS Micro Drivers because silicone potting failed to cure properly, which could cause material leakage or electrical malfunction.

    Product
    REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1879-2013·2013-08-14

    Stryker Sonopet Ultrasonic Aspirator Console Recalled for Corrosion

    Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working.

    Product
    Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1878-2013·2013-08-14

    Stryker Sonopet Ultrasonic Aspirator Console Recall for Corrosion Defect

    Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working during surgery.

    Product
    Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointest
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2013·2013-08-14

    Stryker Recalls Sonopet Ultrasonic Aspirator Consoles Due to Corrosion

    Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working.

    Product
    Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2013·2013-07-24

    Stryker CORE Universal Driver Recalled for Unintended Activation Risk

    Stryker is recalling 11 CORE Universal Drivers because incorrect programming parameters may cause unintended activation, posing a potential injury risk to patients and users.

    Product
    CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2013·2013-07-24

    Stryker RemB Electric Universal Driver Recalled for Unintended Activation

    Stryker is recalling nine RemB Electric Universal Drivers because incorrect programming parameters may cause unintended activation, posing a risk of injury to patients or users.

    Product
    RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Un
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2013·2013-07-24

    Stryker TPS Universal Driver Recalled for Unintended Activation Risk

    Stryker is recalling TPS Universal Drivers due to incorrect programming that may cause unintended activation, posing a risk of injury to patients or users.

    Product
    Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, max
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1495-2013·2013-06-12

    Stryker T4 Zipper Toga Recall for Potential Sterile Barrier Breach

    Stryker is recalling T4 Zipper Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1489-2013·2013-06-12

    Stryker T4 Pullover Toga Recalled for Potential Sterile Barrier Breach

    Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1493-2013·2013-06-12

    Stryker T4 Toga Pullover Recalled for Potential Sterile Barrier Breach

    Stryker is recalling T4 Toga pullovers because accelerated aging tests suggest the sterile barrier may fail within the second or third year of shelf life.

    Product
    Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1499-2013·2013-06-12

    Stryker T5 Zipper Toga Recalled for Potential Sterile Barrier Breach

    Stryker is recalling T5 Zipper Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1501-2013·2013-06-12

    Stryker T4 Toga Recall Due to Potential Sterile Barrier Breach

    Stryker is recalling T4 Toga sterile surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1504-2013·2013-06-12

    Stryker Toga Recall Due to Potential Sterile Barrier Breach

    Stryker is recalling T5 zipper Toga surgical drapes because accelerated aging tests indicate a potential breach in the sterile barrier within the second and third year of shelf life.

    Product
    Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1502-2013·2013-06-12

    Stryker Instruments T4 Toga Zipper Recall for Sterile Barrier Concerns

    Stryker is recalling T4 Toga Zipper sterile surgical gowns due to potential sterile barrier breaches in packaging identified during accelerated aging tests.

    Product
    Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1496-2013·2013-06-12

    Stryker T4 Zipper Toga Recalled for Potential Sterile Barrier Breach

    Stryker is recalling T4 Zipper Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging during the second and third years of shelf life.

    Product
    Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1491-2013·2013-06-12

    Stryker T5 Pullover Toga Recalled for Potential Sterile Barrier Breach

    Stryker is recalling 1,980 units of T5 Pullover Togas due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1497-2013·2013-06-12

    Stryker T4 Toga Surgical Drapes Recalled for Sterile Barrier Concerns

    Stryker is recalling T4 Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1492-2013·2013-06-12

    Stryker T4 Toga Surgical Gowns Recalled for Potential Sterile Barrier Breach

    Stryker is recalling 3,000 units of T4 Toga surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1500-2013·2013-06-12

    Stryker Instruments T4 Toga Zipper Recall for Sterile Barrier Concerns

    Stryker is recalling 5,000 units of T4 Toga Zipper products due to potential sterile barrier breaches identified in accelerated aging tests.

    Product
    Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1490-2013·2013-06-12

    Stryker T4 Pullover Toga Recall Due to Sterile Barrier Concerns

    Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1494-2013·2013-06-12

    Stryker T4 Toga Pullover Recalled for Potential Sterile Barrier Breach

    Stryker is recalling T4 Toga pullovers because accelerated aging tests indicate a potential breach in the sterile barrier packaging.

    Product
    Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1498-2013·2013-06-12

    Stryker Instruments Toga Sterile Barrier Recall

    Stryker is recalling T4 XXL Toga products due to potential sterile barrier breaches in packaging identified during accelerated aging tests.

    Product
    Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the
    Category
    Medical Device
    Distribution
    Distributed nationwide