Complete FDA and NHTSA recall records dated in 2020, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.
Incorrect product labeling.
Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off
Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.
An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality…
The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg.
The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.
It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the…
The product has an incorrect reference value for cadmium and an incorrect expected range.
The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and…
The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrolled way.
Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers.
Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
There may be dimensional manufacturing error that represents a potential safety risk to patients.
The product presents a significant choking hazard.
Curry powder is contaminated with Salmonella spp. detected by FDA sampling.
Packaging failure that caused leakage.
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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.
