Medical DeviceJul 3, 2019
Tecan US Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such recall — FDA Z-1851-2019
Gas springs not always replaced within the interval specified.
Class IIFDA: TerminatedTecan US, Inc.
26,155medical device recall records
2,290FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.759 records
Database records
Records — page 714
26,155 detailed records are currently available in this category.
Medical DeviceJul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP recall — FDA Z-1852-2019
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…
Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceJul 3, 2019
Thermo Fisher Scientific (Asheville) Fisher Scientific Isotemp -General Purpose Water Bath recall — FDA Z-1865-2019
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…
Class IIFDA: TerminatedThermo Fisher Scientific (Asheville) LLC
Medical DeviceJul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP recall — FDA Z-1853-2019
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…
Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceJul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF recall — FDA Z-1861-2019
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…
Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceJul 3, 2019
GE Healthcare Centricity Universal Viewer with PACS-IW foundation 6.0, Model number recall — FDA Z-1886-2019
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF recall — FDA Z-1863-2019
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…
Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceJul 3, 2019
Qiagen Sciences RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit recall — FDA Z-1891-2019
The deparaffinization solution contains a contaminant, which leads to reduced lysis efficiency of the affected lot, resulting in significantly reduced yields and less sensitive downstream…
Class IIFDA: TerminatedQiagen Sciences, Inc.
Medical DeviceJul 3, 2019
Hitachi America, Ltd., Power Systems Division PROBEAT-V, software versions 4.8.1S, and 5.1M recall — FDA Z-1892-2019
There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.
Class IIFDA: TerminatedHitachi America, Ltd., Power Systems Division
Medical DeviceJul 3, 2019
Vyaire Medical enFlow Disposable Cartridge, used for intravenous warming therapy with fluid recall — FDA Z-1385-2019
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Class IFDA: TerminatedVyaire Medical
Medical DeviceJul 3, 2019
Medtronic Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of recall — FDA Z-1880-2019
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the…
Class IIFDA: TerminatedMedtronic Inc.
Medical DeviceJul 3, 2019
Vyaire Medical enFlow Disposable Cartridge with IV Extension Set, used for intravenous recall — FDA Z-1386-2019
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Class IFDA: TerminatedVyaire Medical
Medical DeviceJul 3, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath recall — FDA Z-1873-2019
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…
Class IIFDA: TerminatedThermo Fisher Scientific (Asheville) LLC
Medical DeviceJul 3, 2019
Medtronic Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement recall — FDA Z-1882-2019
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the…
Class IIFDA: TerminatedMedtronic Inc.
Medical DeviceJul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP recall — FDA Z-1854-2019
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…
Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceJul 3, 2019
GE Healthcare Replacement ECG leadwires with snap ends REF/Catalog Number Description recall — FDA Z-1879-2019
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
Class IIIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJul 3, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF recall — FDA Z-1862-2019
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…
Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceJul 3, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath recall — FDA Z-1870-2019
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…
Class IIFDA: TerminatedThermo Fisher Scientific (Asheville) LLC
Medical DeviceJul 3, 2019
GE Healthcare ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire recall — FDA Z-1876-2019
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
Class IIIFDA: TerminatedGE Healthcare, LLC
Medical DeviceJul 3, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath recall — FDA Z-1869-2019
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…
Class IIFDA: TerminatedThermo Fisher Scientific (Asheville) LLC
Medical DeviceJul 3, 2019
Medtronic Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of recall — FDA Z-1883-2019
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the…
Class IIFDA: TerminatedMedtronic Inc.
Medical DeviceJul 3, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath recall — FDA Z-1872-2019
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…
Class IIFDA: TerminatedThermo Fisher Scientific (Asheville) LLC
Medical DeviceJul 3, 2019
AtriCure EPi-Sense Guided Coagulation System with Visitrax, MOdel No recall — FDA Z-1887-2019
The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used.
Class IIFDA: TerminatedAtriCure, Inc.
Medical DeviceJul 3, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath recall — FDA Z-1871-2019
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…
Class IIFDA: TerminatedThermo Fisher Scientific (Asheville) LLC
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.