Medical DeviceJun 17, 2020
Genicon Natura Model 210-005-051 recall — FDA Z-2273-2020
There is potential for the plastic optical tip to become detached from the metal shaft.
Class IIFDA: OngoingGenicon, Inc.
Monthly breakdown
2020 recalls by month
Select a month to review the recall records reported during that period.
December 2020315 records · 4 categoriesNovember 2020241 records · 4 categoriesOctober 2020416 records · 4 categoriesSeptember 2020371 records · 4 categoriesAugust 2020245 records · 4 categoriesJuly 2020442 records · 4 categoriesJune 2020342 records · 4 categoriesMay 2020315 records · 4 categoriesApril 2020422 records · 4 categoriesMarch 2020368 records · 4 categoriesFebruary 2020551 records · 4 categoriesJanuary 2020224 records · 4 categories
2020 recalls — page 90
Records are ordered by the best available source date.
Medical DeviceJun 17, 2020
Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage recall — FDA Z-2304-2020
Distributed to the field without having completed design history files or design transfer activities
Class IIFDA: TerminatedBiomet
Medical DeviceJun 17, 2020
Canon Medical System, USA Infinix-8000V with Catheterization Table CAT-850B or CAT-860B recall — FDA Z-2325-2020
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceJun 17, 2020
Biomet A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 recall — FDA Z-2308-2020
Distributed to the field without having completed design history files or design transfer activities
Class IIFDA: TerminatedBiomet
Medical DeviceJun 17, 2020
Genicon GENILook Model 200-005-153 recall — FDA Z-2268-2020
There is potential for the plastic optical tip to become detached from the metal shaft.
Class IIFDA: OngoingGenicon, Inc.
Medical DeviceJun 17, 2020
Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage recall — FDA Z-2277-2020
There is potential for the plastic optical tip to become detached from the metal shaft.
Class IIFDA: OngoingGenicon, Inc.
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation recall — FDA Z-2344-2020
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) recall — FDA Z-2266-2020
There is potential for the plastic optical tip to become detached from the metal shaft.
Class IIFDA: OngoingGenicon, Inc.
Medical DeviceJun 17, 2020
Siemens Healthcare Diagnostics Atellica CH Fructosamine Reagent (FRUC), Siemens Material recall — FDA Z-2281-2020
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceJun 17, 2020
Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product recall — FDA Z-2270-2020
There is potential for the plastic optical tip to become detached from the metal shaft.
Class IIFDA: OngoingGenicon, Inc.
Medical DeviceJun 17, 2020
Acuity Surgical Devices A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A recall — FDA Z-2354-2020
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Class IIFDA: OngoingAcuity Surgical Devices, LLC
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 9B Service Pack 1, UDI # 07350002010297 - Product recall — FDA Z-2351-2020
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
Ventana Medical Systems Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The recall — FDA Z-2262-2020
The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology…
Class IIFDA: CompletedVentana Medical Systems Inc.
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation recall — FDA Z-2346-2020
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number recall — FDA Z-2319-2020
Distributed to the field without having completed design history files or design transfer activities
Class IIFDA: TerminatedBiomet
Medical DeviceJun 17, 2020
RAYSEARCH LABORATORIES AB RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation recall — FDA Z-2349-2020
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 17, 2020
Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number recall — FDA Z-2309-2020
Distributed to the field without having completed design history files or design transfer activities
Class IIFDA: TerminatedBiomet
Medical DeviceJun 17, 2020
Eizo RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for recall — FDA Z-2294-2020
Under certain conditions, a marble pattern infrequently appears on the monitor.
Class IIFDA: OngoingEizo Corporation
Medical DeviceJun 17, 2020
Acuity Surgical Devices A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A recall — FDA Z-2355-2020
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Class IIFDA: OngoingAcuity Surgical Devices, LLC
Medical DeviceJun 17, 2020
Eizo RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage recall — FDA Z-2293-2020
Under certain conditions, a marble pattern infrequently appears on the monitor.
Class IIFDA: OngoingEizo Corporation
Medical DeviceJun 17, 2020
Biomet A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number recall — FDA Z-2315-2020
Distributed to the field without having completed design history files or design transfer activities
Class IIFDA: TerminatedBiomet
Medical DeviceJun 17, 2020
Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number recall — FDA Z-2324-2020
Distributed to the field without having completed design history files or design transfer activities
Class IIFDA: TerminatedBiomet
Medical DeviceJun 17, 2020
Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item recall — FDA Z-2312-2020
Distributed to the field without having completed design history files or design transfer activities
Class IIFDA: TerminatedBiomet
Medical DeviceJun 17, 2020
Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number recall — FDA Z-2311-2020
Distributed to the field without having completed design history files or design transfer activities
Class IIFDA: TerminatedBiomet
About the 2020 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.