Medical DeviceOct 3, 2018
Tosoh Bioscience G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use recall — FDA Z-3244-2018
Analyzers were distributed with software which lacks a 510K
Class IIFDA: TerminatedTosoh Bioscience Inc.
Monthly breakdown
2018 recalls by month
Select a month to review the recall records reported during that period.
December 2018285 records · 4 categoriesNovember 2018342 records · 4 categoriesOctober 2018626 records · 4 categoriesSeptember 2018393 records · 4 categoriesAugust 2018569 records · 4 categoriesJuly 2018356 records · 4 categoriesJune 2018402 records · 4 categoriesMay 2018613 records · 4 categoriesApril 2018449 records · 3 categoriesMarch 2018523 records · 3 categoriesFebruary 2018373 records · 3 categoriesJanuary 2018162 records · 2 categories
2018 recalls — page 51
Records are ordered by the best available source date.
Medical DeviceOct 3, 2018
Boston Scientific ACCOLADE Pacemaker recall — FDA Z-3257-2018
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery…
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceOct 3, 2018
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga recall — FDA Z-3273-2018
The back cap separates from the body of the vitrectomy cutter.
Class IIFDA: TerminatedBausch & Lomb Inc.
Medical DeviceOct 3, 2018
Zimmer Biomet Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment recall — FDA Z-3250-2018
The implant only has one bolt in the sterile package but it should have had two.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceOct 3, 2018
Philips Electronics Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular recall — FDA Z-3234-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Agfa N.V DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General recall — FDA Z-3245-2018
A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if…
Class IIFDA: TerminatedAgfa N.V.
Medical DeviceOct 3, 2018
Philips Electronics INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and recall — FDA Z-3213-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Philips Electronics AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and recall — FDA Z-3226-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Philips Electronics Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular recall — FDA Z-3223-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Boston Scientific PROPONENT Pacemaker recall — FDA Z-3256-2018
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery…
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceOct 3, 2018
Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga recall — FDA Z-3270-2018
The back cap separates from the body of the vitrectomy cutter.
Class IIFDA: TerminatedBausch & Lomb Inc.
Medical DeviceOct 3, 2018
Philips Electronics Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular recall — FDA Z-3235-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Philips Electronics NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and recall — FDA Z-3220-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Philips Electronics INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular recall — FDA Z-3216-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Biomet UK HipLOC Hip Fracture Fixation System- Hiploc System 130 Plate 38 mm Barrel 4 Hole recall — FDA Z-3261-2018
HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
Class IIFDA: TerminatedBiomet UK Ltd.
Medical DeviceOct 3, 2018
Philips Electronics Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and recall — FDA Z-3222-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga recall — FDA Z-3269-2018
The back cap separates from the body of the vitrectomy cutter.
Class IIFDA: TerminatedBausch & Lomb Inc.
Medical DeviceOct 3, 2018
Stryker GmbH Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF recall — FDA Z-3240-2018
When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an…
Class IIFDA: TerminatedStryker GmbH
Medical DeviceOct 3, 2018
Philips Electronics INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular recall — FDA Z-3214-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Philips Electronics Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and recall — FDA Z-3221-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Philips Electronics AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular recall — FDA Z-3231-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Philips Electronics INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and recall — FDA Z-3218-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga recall — FDA Z-3267-2018
The back cap separates from the body of the vitrectomy cutter.
Class IIFDA: TerminatedBausch & Lomb Inc.
Medical DeviceOct 3, 2018
Boston Scientific VALITUDE X4 CRT-P recall — FDA Z-3258-2018
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery…
Class IIFDA: TerminatedBoston Scientific Corporation
About the 2018 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.