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Stryker Instruments Div. of Stryker Recalls
161 recalls on record · June 20, 2012 to July 27, 2022 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 27, 2022Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, re
Hazard: When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.
July 27, 2022Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label
Hazard: Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.
July 27, 2022Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Hazard: Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.
November 18, 2020Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cut
Hazard: Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
May 6, 2020Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smo
Hazard: Due to a distribution error, product from the affected lot was shipped expired.
February 12, 2020Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compresse
Hazard: Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
February 12, 2020Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long co
Hazard: Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
February 12, 2020Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches l
Hazard: Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
December 11, 2019Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector,
Hazard: There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
December 11, 2019Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connecto
Hazard: There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
October 9, 2019Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended
Hazard: Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.
October 9, 2019Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended
Hazard: Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.
May 1, 2019Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades
Hazard: During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
May 2, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
Hazard: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
May 2, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
Hazard: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
May 2, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
Hazard: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
May 2, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment
Hazard: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
May 2, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
Hazard: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
May 2, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
Hazard: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
May 2, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
Hazard: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
May 2, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment
Hazard: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
May 2, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment
Hazard: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
May 2, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
Hazard: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
May 2, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
Hazard: Separation of material layers may occur, causing a potential risk of exposure to contaminants.
April 4, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
Hazard: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
April 4, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product
Hazard: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
April 4, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
Hazard: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
April 4, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for
Hazard: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
April 4, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
Hazard: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
April 4, 2018Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product N
Hazard: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.