Recall archive
48 recalls · page 1 of 2
Reported Jul 27, 2022
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Stryker Instruments Div.
Matched: Brand — Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 18, 2020
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported May 6, 2020
Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand — Due to a distribution error, product from the affected lot was shipped expired.
FDA (openFDA device enforcement)
Reported Feb 12, 2020
SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand — 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.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2019
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product details — There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2019
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Reason for recall — Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 1, 2019
Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in…
FDA (openFDA device enforcement)
Reported May 2, 2018
T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand — Separation of material layers may occur, causing a potential risk of exposure to contaminants.
10 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 4, 2018
The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details · Reason for recall — Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in…
13 more products in this recall
FDA (openFDA device enforcement)
Reported May 17, 2017
Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — Product shipped proximate to or past the expiration date listed on the product label.
FDA (openFDA device enforcement)
Reported May 3, 2017
Stryker SmartLife Large Aseptic Housing (7126-120-000)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details · Reason for recall — Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLife Large Aseptic Housings following…
FDA (openFDA device enforcement)
Reported Dec 28, 2016
8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details · Reason for recall — Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2016
RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Stryker Instruments Div.
Matched: Brand · Reason for recall — Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator,…
FDA (openFDA device enforcement)
Reported Oct 26, 2016
Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Reason for recall — Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a sterile barrier breach in the product's…
FDA (openFDA device enforcement)
Reported Aug 31, 2016
120 V Neptune 3 Rover, Model Number: 0703-001-000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Reason for recall — Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors…
FDA (openFDA device enforcement)
Reported Aug 24, 2016
Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the…
FDA (openFDA device enforcement)
Reported Jul 27, 2016
2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product details — A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk…
FDA (openFDA device enforcement)
Reported Jul 20, 2016
5.0mm Round Fluted Bur, Super Long
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Reason for recall — Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 15, 2016
Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pneumatically operated surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product details — Due to the buildup of grease within the hose and motor, the product may require multiple attempts to start. The grease may also migrate into the…
FDA (openFDA device enforcement)
Reported Apr 20, 2016
Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product details — The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembly included in the packaging is the incorrect size.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 9, 2016
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — 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…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 23, 2015
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. There is a…
FDA (openFDA device enforcement)
Reported Sep 9, 2015
Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the…
FDA (openFDA device enforcement)
Reported Jul 29, 2015
0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details · Reason for recall — Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to complaints related to installation failures of the Neptune…
1 more product in this recall
FDA (openFDA device enforcement)
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