Stryker Medical Division recalls
Stryker Medical Division appears in 80 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets
FDA Device · Class II · 2018-02-07 · Stryker Medical Division
Reason: It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied w… - Medi-Therm Hyper/Hypothermia System, MTA7900
FDA Device · Class II · 2017-05-17 · Stryker Medical Division
Reason: 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 "Automatic" mode. - Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled
FDA Device · Class II · 2016-12-21 · Stryker Medical Division
Reason: Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD… - S3 MedSurg Bed, Model 3005
FDA Device · Class II · 2016-08-17 · Stryker Medical Division
Reason: CPU board failures cause fowler (backrest) electronic controls to stop working. - Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and tran…
FDA Device · Class II · 2016-06-22 · Stryker Medical Division
Reason: 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 placing the battery into the cot. In addition to the alleged smoking,… - Spirit One A-C Powered Hospital Bed
FDA Device · Class II · 2016-05-04 · Stryker Medical Division
Reason: Inaccurate scale systems - Spirit One A-C Powered Hospital Bed
FDA Device · Class II · 2016-05-04 · Stryker Medical Division
Reason: Customer complaints associated with faulty brake system - Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher
FDA Device · Class II · 2016-03-23 · Stryker Medical Division
Reason: 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 used does not contain the same wear resistance additives as the specified… - Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher
FDA Device · Class II · 2016-03-23 · Stryker Medical Division
Reason: 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 used does not contain the same wear resistance additives as the specified… - Stryker Position Pro Mattress
FDA Device · Class II · 2016-03-16 · Stryker Medical Division
Reason: Potential for power cord to melt; hazards include electric shock and fire. - Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher
FDA Device · Class II · 2015-12-09 · Stryker Medical Division
Reason: 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 investigation was initiated which identified that the I.V. Latch Housi… - InTouch Critical Care Bed, Stryker Medical
FDA Device · Class II · 2014-08-06 · Stryker Medical Division
Reason: 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 fallen off. The investigations into these casters have shown that in th… - The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connect…
FDA Device · Class II · 2014-02-12 · Stryker Medical Division
Reason: 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. While in Auto mode, only the patient temperature is displayed along with t… - S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals
FDA Device · Class II · 2014-01-08 · Stryker Medical Division
Reason: 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. The affected beds have the potential to experience damage to the Foot En… - Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals
FDA Device · Class II · 2014-01-08 · Stryker Medical Division
Reason: 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. The affected beds have the potential to experience damage to the Foot En… - Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with…
FDA Device · Class II · 2013-11-27 · Stryker Medical Division
Reason: 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 and/or lacerations to a patient who is leaning against the siderails if the… - The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medi…
FDA Device · Class II · 2013-10-02 · Stryker Medical Division
Reason: 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 pole) is inserted into this slot, the circuit directing the nurse call sy… - IsoGel AIR 84, Support Surface
FDA Device · Class II · 2013-08-21 · Stryker Medical Division
Reason: Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon furt… - Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 is intended to support and transport patients wit…
FDA Device · Class II · 2013-01-09 · Stryker Medical Division
Reason: Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the b… - Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/…
FDA Device · Class II · 2013-01-09 · Stryker Medical Division
Reason: 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 brake rings that do not meet specifications, negatively impacting the hold… - The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of…
FDA Device · Class II · 2012-12-26 · Stryker Medical Division
Reason: 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 specifications causing the lifting ability of the arms to be negative… - Powered Mobility Offers Versatility (M¿V)TM Chair
FDA Device · Class II · 2012-08-29 · Stryker Medical Division
Reason: Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Pa… - Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two opera…
FDA Device · Class II · 2012-08-29 · Stryker Medical Division
Reason: Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Pa… - Powered Mobility Offers Versatility (M¿V)TM Chair
FDA Device · Class II · 2012-08-29 · Stryker Medical Division
Reason: Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Pa… - Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two opera…
FDA Device · Class II · 2012-08-29 · Stryker Medical Division
Reason: Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Pa… - Go Bed II+ Model FL28C Beds are intended for medical purposes in both general patient care as well as critical care environments
FDA Device · Class II · 2012-07-04 · Stryker Medical Division
Reason: An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral compone… - Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments
FDA Device · Class II · 2012-07-04 · Stryker Medical Division
Reason: An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral compone… - Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in both general patient care as well as critical care environments
FDA Device · Class II · 2012-07-04 · Stryker Medical Division
Reason: An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral compone… - Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both general patient care as well as critical care environments
FDA Device · Class II · 2012-07-04 · Stryker Medical Division
Reason: An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral compone… - GoBed+ . Model FL20E Beds are intended for medical purposes in both general patient care as well as critical care environments
FDA Device · Class II · 2012-07-04 · Stryker Medical Division
Reason: An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral compone…