Recall archive
48 recalls · page 2 of 2
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 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 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)
Reported Jun 11, 2014
The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details · Reason for recall — The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2014
Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier.…
FDA (openFDA device enforcement)
Reported Mar 26, 2014
2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive…
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 single use 2.5MM Aggressive Blade because the line on the affected part (P/N 5290-928-000, Lot…
FDA (openFDA device enforcement)
Reported Feb 12, 2014
Neptune 2 Rover Ultra Waste Management System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand — The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2014
Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — The Color Cuff¿ Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. A customer reported having…
FDA (openFDA device enforcement)
Reported Nov 20, 2013
Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand — On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. H). On March 15, 2013, when…
FDA (openFDA device enforcement)
Reported Nov 13, 2013
Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Reason for recall — Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the…
FDA (openFDA device enforcement)
Reported Nov 6, 2013
REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to…
FDA (openFDA device enforcement)
Reported Aug 14, 2013
Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand — A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2013
Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2013
Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details · Reason for recall — Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header…
15 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 12, 2012
Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Reason for recall — Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 22, 2012
Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
High riskUsing this product could cause serious injury, illness or death — stop using it now.Stryker Instruments Div.
Matched: Brand · Product · Product details · Reason for recall — Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 8, 2012
RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF…
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 has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 20, 2012
T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Reason for recall — The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of…
1 more product in this recall
FDA (openFDA device enforcement)
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