Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-07-03FDA-DeviceThermo Fisher Scientific (Asheville) LLCClass IIThermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath Model Number: TSGP15D
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
- 2019-07-03FDA-DeviceThermo Fisher Scientific (Asheville) LLCClass IIThermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath Model Number: TSGP2S
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
- 2019-07-03FDA-DeviceThermo Fisher Scientific (Asheville) LLCClass IIThermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model Number: TSGP20
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
- 2019-07-03FDA-DeviceThermo Fisher Scientific (Asheville) LLCClass IIThermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
- 2019-07-03FDA-DeviceThermo Fisher Scientific (Asheville) LLCClass IIFisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
- 2019-07-03FDA-DeviceThermo Fisher Scientific (Asheville) LLCClass IIFisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
- 2019-07-03FDA-DeviceThermo Fisher Scientific (Asheville) LLCClass IIFisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
- 2019-07-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- 2019-07-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- 2019-07-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- 2019-07-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- 2019-07-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- 2019-07-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- 2019-07-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- 2019-07-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- 2019-07-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- 2019-07-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- 2019-07-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- 2019-07-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- 2019-07-03FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMaquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- 2019-07-03FDA-DeviceTecan US, Inc.Class IIFreedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.
Gas springs not always replaced within the interval specified.
- 2019-07-03FDA-DeviceCOLLINS AEROSPACEClass IITASE 500 Imaging systems
the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.
- 2019-07-03FDA-DeviceCOLLINS AEROSPACEClass IITASE 400 Imaging systems
the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.
- 2019-07-03FDA-DeviceVyaire MedicalClass IenFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
- 2019-07-03FDA-DeviceVyaire MedicalClass IenFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
- 2019-07-03FDA-DeviceBecton Dickinson & CompanyClass ISmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.
- 2019-06-26FDA-DeviceArkray Factory USA, Inc.Class IIAUTION HYBRID AU-4050
This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.
- 2019-06-26FDA-DeviceStryker GmbHClass IIEndotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
The seal integrity of the sterile bag containing the kits may be compromised.
- 2019-06-26FDA-DeviceStryker GmbHClass IIEndotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
The seal integrity of the sterile bag containing the kits may be compromised.
- 2019-06-26FDA-DeviceZimmer Biomet, Inc.Class IIMobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body be
Incorrect part description contained on an additional label placed on the packaging: A 14mm length part was incorrectly labeled as being a 12mm length screw
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