DrugFeb 7, 2024
Rifampin Capsules USP 150mg, 30-count bottle recall — FDA D-0283-2024
Subpotent Drug and Failed Impurities/Degradation Specifications
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
Latest records
Latest recalls — page 451
The newest recall records with useful source details are listed here.
DrugFeb 7, 2024
Den-Mat Holdings Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint recall — FDA D-0287-2024
CGMP Deviations: products may not conform to the labeled specifications.
Class IIFDA: OngoingDen-Mat Holdings, LLC
DrugFeb 7, 2024
Denver Solutions, LLC DBA Leiters Health PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium recall — FDA D-0279-2024
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class IFDA: OngoingDenver Solutions, LLC DBA Leiters Health
DrugFeb 7, 2024
Denver Solutions, LLC DBA Leiters Health FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% recall — FDA D-0278-2024
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class IFDA: OngoingDenver Solutions, LLC DBA Leiters Health
DrugFeb 7, 2024
Denver Solutions, LLC DBA Leiters Health VANCOmycin HCl PF 1.5g added to 0.9% Sodium recall — FDA D-0282-2024
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class IFDA: OngoingDenver Solutions, LLC DBA Leiters Health
DrugFeb 7, 2024
Denver Solutions, LLC DBA Leiters Health FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% recall — FDA D-0277-2024
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class IFDA: OngoingDenver Solutions, LLC DBA Leiters Health
DrugFeb 7, 2024
Denver Solutions, LLC DBA Leiters Health VANCOmycin HCl PF 1.25g added to 0.9% Sodium recall — FDA D-0281-2024
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class IFDA: OngoingDenver Solutions, LLC DBA Leiters Health
VehicleFeb 1, 2024
Honda front passenger recall — NHTSA campaign 24V064000
Honda (American Honda Motor Co.) is recalling certain 2020-2022 Pilot, Accord, Civic sedan, HR-V, Odyssey, 2020 Civic coupe, Fit, 2021-2022 Civic hatchback, 2021 Civic Type R, Insight,…
front passengerHonda (American Honda Motor Co.)
Medical DeviceJan 31, 2024
Medtronic Neuromodulation Model A710 Intellis Clinician Programmer Application, version recall — FDA Z-0780-2024
Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS)…
Class IIFDA: OngoingMedtronic Neuromodulation
Medical DeviceJan 31, 2024
Accure Laser System, Model: PFMS00004 recall — FDA Z-0778-2024
Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.
Class IIFDA: OngoingAccure Acne, Inc.
Medical DeviceJan 31, 2024
KENT IMAGING Snapshot NIR, REF: KD204 recall — FDA Z-0789-2024
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
Class IIFDA: OngoingKENT IMAGING, Inc.
Medical DeviceJan 31, 2024
C.R. Bard Bard Nasogastric Sump Tube and PreVent Filter and Lopez Valve with ENFit, 16Fr. recall — FDA Z-0804-2024
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Class IIFDA: OngoingC.R. Bard Inc.
Medical DeviceJan 31, 2024
C.R. Bard Bard Nasogastric Sump Tube and PreVent Anti-Reflux Filter and Lopez Valve with recall — FDA Z-0802-2024
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Class IIFDA: OngoingC.R. Bard Inc.
Medical DeviceJan 31, 2024
Philips Ingenia Ambition X, Model No. 782109 recall — FDA Z-0810-2024
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background…
Class IIIFDA: OngoingPhilips North America
Medical DeviceJan 31, 2024
Philips Achieva 1.5T Conversion, Model No. 781283 recall — FDA Z-0808-2024
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background…
Class IIIFDA: OngoingPhilips North America
Medical DeviceJan 31, 2024
Beckman Coulter REV 2 Flowcell Capsule Spare, Part Number: C04154 recall — FDA Z-0786-2024
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate…
Class IIFDA: OngoingBeckman Coulter, Inc.
Medical DeviceJan 31, 2024
B-K Medical A/S bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66 recall — FDA Z-0813-2024
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
Class IIFDA: OngoingB-K Medical A/S
Medical DeviceJan 31, 2024
Medtronic Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number recall — FDA Z-0779-2024
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This…
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceJan 31, 2024
Philips Achieva 1.5T, Model No. 781178, 781196, 781296 recall — FDA Z-0807-2024
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background…
Class IIIFDA: OngoingPhilips North America
Medical DeviceJan 31, 2024
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 recall — FDA Z-0815-2024
DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG…
Class IIFDA: OngoingDiasorin Inc.
Medical DeviceJan 31, 2024
Philips Intera 1.5T, Model No. 781195 recall — FDA Z-0811-2024
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background…
Class IIIFDA: OngoingPhilips North America
Medical DeviceJan 31, 2024
Sedecal X Optima URS digital mobile diagnostic x-ray system recall — FDA Z-0781-2024
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Class IIFDA: OngoingSEDECAL SA
Medical DeviceJan 31, 2024
Philips SmartPath to dStream for 1.5T, Model No. 781260, 782112 recall — FDA Z-0812-2024
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background…
Class IIIFDA: OngoingPhilips North America
Medical DeviceJan 31, 2024
C.R. Bard Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 16Fr., 48in recall — FDA Z-0799-2024
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Class IIFDA: OngoingC.R. Bard Inc.
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Recent recall archives
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