Complete FDA and NHTSA recall records dated in August 2022.
These records include useful source details for the selected month.
BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss…
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect…
Kits contain leaking bottles of isopropyl alcohol
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the…
Kits contain leaking bottles of isopropyl alcohol
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical…
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
Kits contain leaking bottles of isopropyl alcohol
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
Kits contain leaking bottles of isopropyl alcohol
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1.…
Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical…
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
The product may be potentially positive for Salmonella due to one of the sub-ingredients (oregano) testing positive for Salmonella.
Listeria monocytogenes contamination.
Detectable levels of Per- and polyfluoroalkyl substances (PFAS).
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Presence of particulate matter: particulate identified as a beetle.
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.
