Complete FDA and NHTSA recall records dated in September 2019.
These records include useful source details for the selected month.
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the Tina-quant Myoglobin Gen.2 assay (catalog…
software error in the central control unit of the floor stand.
SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected…
software error in the central control unit of the floor stand.
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
The mounts on the monitor may have an insufficient weld.
incorrect device size being listed on the impacted device packaging
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Nice! Brand Espresso Trail Mix because of undeclared Sulfites.
undeclared walnuts
Herbal Tea product is recalled due to a potential contamination with Salmonella.
The firm stated that they placed Peach Tea Labels on Diet Peach Tea bottles. The product contains undeclared Malic Acid and Citrus Pectin.
Herbal Tea product is recalled due to a potential contamination with Salmonella.
Herbal Tea product is recalled due to a potential contamination with Salmonella.
General Motors LLC (GM) is recalling certain 2020 Buick Enclave and Chevrolet Traverse vehicles. The right-hand frame rail in the engine compartment may be cracked.
Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations…
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The seal integrity of the sterile bag containing the kits may be compromised.
When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a mismatch…
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
code 7-102 Liquid Sensor Error
Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
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.
