Recall archive
121 recalls · page 5 of 6
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 Feb 12, 2014
The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Reason for recall — Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode.…
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 Jan 8, 2014
Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Reason for recall — Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2013
Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises…
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 Oct 2, 2013
The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV…
FDA (openFDA device enforcement)
Reported Aug 21, 2013
IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon…
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 Apr 17, 2013
Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details · Reason for recall — Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.
FDA (openFDA device enforcement)
Reported Jan 9, 2013
Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Reason for recall — Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. The affected beds may have been built with…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 26, 2012
The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Product · Product details — Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have been built with a load switch slide that does not meet…
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 29, 2012
Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Reason for recall — Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of…
3 more products 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 Jul 4, 2012
GoBed+ . Model FL20E Beds are intended for medical purposes in both general patient care as well as critical care…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation…
4 more products in this recall
FDA (openFDA device enforcement)
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