Medical DeviceAug 14, 2019
Opternative The Visibly Online Refractive Vision Test which is part of the Visibly Vision recall — FDA Z-2223-2019
Lack of 510K clearance
Class IIFDA: OngoingOpternative Inc.
Latest records
Latest recalls — page 1185
The newest recall records with useful source details are listed here.
Medical DeviceAug 14, 2019
Philips Medical Systems (Cleveland) Vereos PET/CT Model # 882446, computed tomography x-ray recall — FDA Z-2194-2019
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceAug 14, 2019
Centurion Medical Products STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This recall — FDA Z-2162-2019
Potential for sterile packaging to be compromised
Class IIFDA: TerminatedCenturion Medical Products Corporation
Medical DeviceAug 14, 2019
Centurion Medical Products CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used recall — FDA Z-2164-2019
Potential for sterile packaging to be compromised
Class IIFDA: TerminatedCenturion Medical Products Corporation
Medical DeviceAug 14, 2019
SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous recall — FDA Z-2156-2019
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
Class IIFDA: TerminatedSenTec AG
Medical DeviceAug 14, 2019
Medical Components, Inc dba MedComp 14F x 30CM SLX Double Lumen Full Tray Hemodialysis recall — FDA Z-2217-2019
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Class IIFDA: TerminatedMedical Components, Inc dba MedComp
Medical DeviceAug 14, 2019
Philips Medical Systems (Cleveland) Ingenuity Core Model # 728321, computed tomography x-ray recall — FDA Z-2188-2019
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceAug 14, 2019
Gk Photonics Atom Laser Projection Series recall — FDA Z-2093-2019
The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could…
Class IIFDA: OngoingGk Photonics Inc.
Medical DeviceAug 14, 2019
MED-EL Elektromedizinische Gereate, Gmbh MED EL Cochlear Implant System, PULSARci100 recall — FDA Z-2138-2019
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Class IIFDA: TerminatedMED-EL Elektromedizinische Gereate, Gmbh
Medical DeviceAug 14, 2019
Siemens Medical Solutions USA Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis recall — FDA Z-2195-2019
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 14, 2019
Fresenius Medical Care Renal Therapies Group Liberty Cycler Cassettes recall — FDA Z-2151-2019
Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler…
Class IIFDA: TerminatedFresenius Medical Care Renal Therapies Group, LLC
Medical DeviceAug 14, 2019
Gk Photonics Maxim Laser Projection Series recall — FDA Z-2095-2019
The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could…
Class IIFDA: OngoingGk Photonics Inc.
Medical DeviceAug 14, 2019
Bard Peripheral Vascular EnCor Breast Biopsy Probes, packaged individually in sterile recall — FDA Z-2209-2019
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceAug 14, 2019
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product recall — FDA Z-2148-2019
There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
Class IIFDA: TerminatedOlympus Corporation of the Americas
Medical DeviceAug 14, 2019
Medical Components, Inc dba MedComp 14F x 20CM SLX Double Lumen Full Tray Hemodialysis recall — FDA Z-2215-2019
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Class IIFDA: TerminatedMedical Components, Inc dba MedComp
Medical DeviceAug 14, 2019
Philips Medical Systems (Cleveland) iCT SP Model # 728311, computed tomography x-ray system recall — FDA Z-2190-2019
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceAug 14, 2019
DRG Instruments GmbH DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in recall — FDA Z-2159-2019
Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were…
Class IIFDA: TerminatedDRG Instruments GmbH
Medical DeviceAug 14, 2019
St Jude Medical ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI recall — FDA Z-2075-2019
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated.…
Class IFDA: TerminatedSt Jude Medical Inc.
Medical DeviceAug 14, 2019
Bard Peripheral Vascular EnCor Breast Biopsy Probes, packaged individually in sterile recall — FDA Z-2212-2019
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceAug 14, 2019
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For recall — FDA Z-2146-2019
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
Class IIFDA: TerminatedGeistlich Pharma North America, Inc.
Medical DeviceAug 14, 2019
MED-EL Elektromedizinische Gereate, Gmbh MED EL Cochlear Implant System, SONATATIi100, sold recall — FDA Z-2137-2019
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Class IIFDA: TerminatedMED-EL Elektromedizinische Gereate, Gmbh
Medical DeviceAug 14, 2019
St Jude Medical ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI recall — FDA Z-2072-2019
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated.…
Class IFDA: TerminatedSt Jude Medical Inc.
Medical DeviceAug 14, 2019
Bard Peripheral Vascular EnCor Breast Biopsy Probes, packaged individually in sterile recall — FDA Z-2211-2019
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceAug 14, 2019
Gk Photonics Logolas Laser Projection Series recall — FDA Z-2096-2019
The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could…
Class IIFDA: OngoingGk Photonics Inc.
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026180 records · 4 categoriesSeptember 2026363 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories