DrugAug 21, 2019
Infusion Options LEUCOVORIN 560 MG / 250 ML NS IVPB recall — FDA D-1789-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
August 2019 recalls — page 12
These records include useful source details for the selected month.
DrugAug 21, 2019
US Pharmaceuticals Adult Glycerin Suppositories, Package Size 50-count suppositories recall — FDA D-1729-2019
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class IIFDA: TerminatedUS Pharmaceuticals Inc.
DrugAug 21, 2019
US Pharmaceuticals Adult Glycerin Suppositories, Package Size 100-count suppositories recall — FDA D-1730-2019
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class IIFDA: TerminatedUS Pharmaceuticals Inc.
DrugAug 21, 2019
US Pharmaceuticals CRYO-273 Cold Pain Relieving Gel 128 FL recall — FDA D-1741-2019
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class IIFDA: TerminatedUS Pharmaceuticals Inc.
DrugAug 21, 2019
Infusion Options Gemcitabine 1910 MG / 250 ML NS IVPB recall — FDA D-1781-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G recall — FDA D-1760-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options Fluorouracil 560 MG / 11.2 ML IVP Fluorouracil 3340 MG QS 92 ML 0.9% NACL recall — FDA D-1779-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
DrugAug 21, 2019
Infusion Options DOCETAXEL 60 MG / 250 ml D5W IVPB recall — FDA D-1769-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedInfusion Options, Inc.
VehicleAug 21, 2019
Atlas tank recall — NHTSA campaign 19V614000
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2019 Atlas vehicles. The suction jet in the fuel tank may have been welded in the incorrect position allowing fuel to…
tankVolkswagen Group of America, Inc.
Medical DeviceAug 14, 2019
Bard Peripheral Vascular EnCor Breast Biopsy Probes, packaged individually in sterile recall — FDA Z-2210-2019
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
Biomet 3i CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product recall — FDA Z-2144-2019
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceAug 14, 2019
Gk Photonics Spectrum Laser Projection Series recall — FDA Z-2094-2019
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
Gk Photonics ClubMax Laser Projection Series recall — FDA Z-2092-2019
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
Siemens Medical Solutions USA Lantis system (pre-2003), Model #5835991 - Product Usage recall — FDA Z-2198-2019
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 14, 2019
St Jude Medical ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) recall — FDA Z-2070-2019
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
Philips Medical Systems (Cleveland) IQon Spectral CT Model # 728332, computed tomography recall — FDA Z-2192-2019
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
Medline Industries Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product recall — FDA Z-2203-2019
Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceAug 14, 2019
Abbott Ireland Diagnostics Division Alinity i Ferritin Reagent Kit, List Number 07P6530 The recall — FDA Z-2208-2019
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is…
Class IIFDA: TerminatedAbbott Ireland Diagnostics Division
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.
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
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.