Recall archive
121 recalls · page 3 of 6
Reported Nov 21, 2018
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 31, 2018
Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5¿C while in Automatic mode. 2. Users…
FDA (openFDA device enforcement)
Reported Sep 26, 2018
IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Product details — Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.
FDA (openFDA device enforcement)
Reported Jun 13, 2018
3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — Inadvertent shipment of expired units.
FDA (openFDA device enforcement)
Reported May 9, 2018
6376 M-1 Cot Fastener, catalog no. 6376000000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
1 more product in this recall
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 25, 2018
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
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 Mar 21, 2018
CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated…
FDA (openFDA device enforcement)
Reported Mar 21, 2018
T/Pump temperature therapy pump, Models TP700 and TP700C
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Stryker Medical Division
Matched: Brand — The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat…
FDA (openFDA device enforcement)
Reported Mar 14, 2018
StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2018
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at…
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 17, 2017
Medi-Therm Hyper/Hypothermia System, MTA7900
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to…
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 Dec 21, 2016
Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Reason for recall — Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been…
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 Aug 17, 2016
S3 MedSurg Bed, Model 3005. Stryker Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Product · Product details — CPU board failures cause fowler (backrest) electronic controls to stop working.
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)
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