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.

1–25 of 161

  • HighFDA (Devices)·Z-1402-2022·2022-07-27

    Stryker Triton Canister Scanning Labels Recalled Due to Color Variance

    Stryker is recalling Triton Canister Scanning Labels that may have color variance issues, potentially resulting in lower-than-expected blood loss estimates. The recall affects 16,700 units distributed nationwide.

    Product
    Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2022·2022-07-27

    SurgiCount+ System software error bypasses sponge tracking alerts

    A software error in SurgiCount+ System Application may allow duplicate surgical sponges to be counted without the required documentation prompt. This could allow surgical cases to close without proper verification that all sponges were accounted for.

    Product
    SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1394-2022·2022-07-27

    Triton Sponge System Software Instructions Updated for Proper Sponge Handling

    Stryker is updating the Instructions for Use for the Triton Sponge System software (versions 4.6.5, 4.8.7, 4.9.6) to clarify proper handling technique for sponges and calibration placard. The FDA Class III recall affects 51 units distributed nationwide.

    Product
    Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0431-2021·2020-11-18

    Stryker Recalls Cranial Perforators Due to Potential Metal Fragment Risk

    Stryker is recalling Zyphr Disposable Cranial Perforators because a crack in the inner bit could release metal fragments into the surgical site or cause delayed disengagement.

    Product
    Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1807-2020·2020-05-06

    Stryker Neptune E-SEP Blade Electrode Recalled for Expired Product

    Stryker is recalling 40 units of Neptune E-SEP 165mm Blade Electrodes shipped to Canada because they were expired due to a distribution error.

    Product
    Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosu
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1099-2020·2020-02-12

    Stryker Telescopic Bovie Pencil Recalled for Electrical Arcing Risk

    Stryker is recalling 15,150 telescopic Bovie pencils due to hairline fractures that could cause electrical arcing and burns.

    Product
    Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1097-2020·2020-02-12

    Stryker SafeAir Telescopic Smoke Evacuation Pencil Recalled for Burn Risk

    Stryker is recalling SafeAir Telescopic Smoke Evacuation Pencils because hairline fractures in a component could allow electrical current to arc, potentially causing burns to patients or users.

    Product
    SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2020·2020-02-12

    Stryker Telescopic Smoke Evac Pencil Recalled for Electrical Arcing Risk

    Stryker is recalling Telescopic Smoke Evac Pencils because hairline fractures could cause electrical current to arc, potentially burning patients or users.

    Product
    Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0592-2020·2019-12-11

    Stryker Recalls Disposable Tourniquet Cuffs Due to Air Leak Risk

    Stryker is recalling 16,380 disposable tourniquet cuffs because they may leak air, causing a loss of vascular occlusion during surgery.

    Product
    Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the tempo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0593-2020·2019-12-11

    Stryker Recalls Disposable Tourniquet Cuffs Due to Air Leak Risk

    Stryker is recalling 16,380 disposable tourniquet cuffs because they may leak air, causing a loss of vascular occlusion during surgery.

    Product
    Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the tempora
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2020·2019-10-09

    Stryker C2 Nerve Monitor Recalled for Potential Nerve Injury Risk

    Stryker is recalling 135 C2 Nerve Monitor units because design and instruction issues may lead to use errors that cause nerve injury.

    Product
    C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surger
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2020·2019-10-09

    Stryker Recalls C2 Nerve Monitor Due to Usability Design Issues

    Stryker is recalling 135 C2 Nerve Monitor units because design and instruction usability issues may lead to use errors and potential nerve injury.

    Product
    C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surger
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2019·2019-05-01

    Stryker Performance Series Sagittal Blade Recall for Sterility Breach

    Stryker is recalling 355 Performance Series Sagittal Blades due to a potential breach in sterility caused by improper packaging positioning during manufacture.

    Product
    Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee, uni-compart
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1509-2018·2018-05-02

    Stryker T4 Zipper Toga Recall Due to Material Separation Risk

    Stryker is recalling T4 Zipper Toga sterile garments because material layers may separate, creating a risk of exposure to contaminants.

    Product
    T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1505-2018·2018-05-02

    Stryker T4 Zipper Toga sterile garments recalled for layer separation

    Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.

    Product
    T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1504-2018·2018-05-02

    Stryker Recalls T4 Pullover Toga Due to Material Separation Risk

    Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, creating a potential risk of exposure to contaminants.

    Product
    T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1507-2018·2018-05-02

    Stryker T5 Zipper Toga Sterile Garment Recall for Layer Separation

    Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.

    Product
    T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1510-2018·2018-05-02

    Stryker T5 Zipper Toga Sterile Garment Recall for Layer Separation

    Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.

    Product
    T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1502-2018·2018-05-02

    Stryker T4 Pullover Toga Recall Due to Layer Separation Risk

    Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.

    Product
    T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1501-2018·2018-05-02

    Stryker T4 Pullover Toga Recalled for Potential Material Separation

    Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.

    Product
    T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1500-2018·2018-05-02

    Stryker T4 Pullover Toga Recalled for Potential Material Separation

    Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.

    Product
    T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1508-2018·2018-05-02

    Stryker T4 Zipper Toga Sterile Garments Recalled for Layer Separation

    Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, posing a risk of exposure to contaminants.

    Product
    T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1506-2018·2018-05-02

    Stryker T4 Zipper Toga Sterile Garment Recall for Layer Separation

    Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.

    Product
    T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2018·2018-05-02

    Stryker T4 Pullover Toga Recall Due to Layer Separation

    Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, creating a risk of exposure to contaminants.

    Product
    T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1244-2018·2018-04-04

    Stryker Recalls 180-Gram Cement Cartridges Due to Sterility Assurance Issues

    Stryker is recalling 708 units of 180-Gram Cement Cartridges with Breakaway Femoral Nozzles because bioburden levels were found to be higher than internal acceptable rates.

    Product
    180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state