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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.
March 9, 2016Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for c
Hazard: During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
December 23, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer
Hazard: The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. There is a potential risk of a soft tissue infection to the patient if device is used after expiration date.
September 9, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Do
Hazard: The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal and cause a leak between the Rover and Docker couplers during docking or leaking from the Rover coupler after docking. The potential hazard is waste fluid and/or fresh water dispensed from the Neptune 2 Rover at the incorrect time.
July 29, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biop
Hazard: Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation.
July 29, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rove
Hazard: Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to complaints related to installation failures of the Neptune 2 diverter valve assembly during docking.
July 22, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Wo
Hazard: Potential sterility breach in the packaging.
June 24, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-0
Hazard: Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main stud and the two flaps on the Articulated Arm was not welded in the correct location, which may result in a potential failure of the arm joint.
June 3, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip
Hazard: Potential for the device cannula to overthrow past the intended length.
May 13, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction wi
Hazard: The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as designed. The firm is initiating a software correction to address the issue.
May 13, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC t
Hazard: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
May 13, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved troc
Hazard: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
May 13, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved troc
Hazard: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
May 13, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved tro
Hazard: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
May 13, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar woun
Hazard: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
May 13, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wou
Hazard: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
May 13, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved troc
Hazard: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
May 13, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wou
Hazard: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
May 13, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved troc
Hazard: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
May 13, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wou
Hazard: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
May 13, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved tro
Hazard: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
May 13, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wo
Hazard: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
February 18, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This
Hazard: A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date should have read 2014-12-01.
February 18, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-steri
Hazard: Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a housing without a continual weld. Customers are instructed to return recalled product to Stryker.
January 21, 2015Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the Su
Hazard: Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.
November 12, 2014Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be
Hazard: The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.
November 12, 2014Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be
Hazard: The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.
August 13, 2014Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
Hazard: The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.
June 18, 2014Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are intended to be used to cut
Hazard: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
June 18, 2014Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related ti
Hazard: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
June 18, 2014Medical DevicesFDA
Stryker Instruments Div. of Stryker Corporation recalls Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone
Hazard: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.