Recall archive
121 recalls · page 4 of 6
Reported Jun 22, 2016
Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Product · Product details — Complaints of smoke coming from the foot end of the cot. This reportedly occurred when either the battery was placed into the cot or shortly after…
FDA (openFDA device enforcement)
Reported Jun 15, 2016
Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the FlowPort II…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details · Reason for recall — Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong…
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 — 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 May 18, 2016
CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Reason for recall — Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 4, 2016
Spirit One A-C Powered Hospital Bed
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — Customer complaints associated with faulty brake system
1 more product in this recall
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 23, 2016
Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 16, 2016
Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Product · Product details — Potential for power cord to melt; hazards include electric shock and fire.
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 Dec 9, 2015
Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An…
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 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)
Reported Jul 22, 2015
0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100-…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product details — Potential sterility breach in the packaging.
FDA (openFDA device enforcement)
Reported Jun 24, 2015
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product details · Reason for recall — Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between…
FDA (openFDA device enforcement)
Reported Jun 3, 2015
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand — Potential for the device cannula to overthrow past the intended length.
FDA (openFDA device enforcement)
Reported May 27, 2015
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details — The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2015
3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar…
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 CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
12 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 18, 2015
System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile…
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 is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a housing without a continual weld. Customers are…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2015
The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand — Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.
FDA (openFDA device enforcement)
Reported Nov 12, 2014
Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 13, 2014
Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive…
FDA (openFDA device enforcement)
Reported Aug 6, 2014
InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Product · Product details · Reason for recall — Stryker has received complaints from the field alleging instances where the In Touch beds are hoisted or lifted from the floor and the casters have…
FDA (openFDA device enforcement)
Reported Jun 18, 2014
Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
31 more products in this recall
FDA (openFDA device enforcement)
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