💊 Drugs Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
All Recalls
95,018 total recalls in our database
💊 Drugs Class I - Dangerous
Subpotent Drug
💊 Drugs Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
💊 Drugs Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
💊 Drugs Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
💊 Drugs Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683
Cardinal Health
💊 Drugs Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
💊 Drugs Class I - Dangerous
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
🏥 Medical Devices Class I - Dangerous
Not manufactured to specification
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
specimens collected in transport media may result is false negative results when stored in certain conditions.
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
Philips Respironics
🏥 Medical Devices Class I - Dangerous
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
🏥 Medical Devices Class I - Dangerous
Not manufactured to specification
🏥 Medical Devices Class I - Dangerous
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
🏥 Medical Devices Class I - Dangerous
Removing parts for safety reasons due to possible breakage.
BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143
Philips Respironics
🏥 Medical Devices Class I - Dangerous
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.
Roche Diagnostics Operations
🏥 Medical Devices Class I - Dangerous
Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.
🏥 Medical Devices Class I - Dangerous
IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result in unforseen events such as mucosal injury, lacerations, or bleeding of the patient. Detachment of the distal end cap (OE-A63) into the oral cavity of the patient may also result in aspiration
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
Philips Respironics
🏥 Medical Devices Class I - Dangerous
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syphilis assay on the ADVIA Centaur XP/XPT or ADVIA Centaur CP systems
🏥 Medical Devices Class I - Dangerous
The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.