Plastikon Healthcare Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup recall — FDA D-1488-2022
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Complete FDA and NHTSA recall records dated in September 2022.
These records include useful source details for the selected month.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2022 TAOS vehicles equipped with all-wheel drive. The engine control unit (ECU) software may cause a stall when coming to…
Ford Motor Company (Ford) is recalling certain 2022 Explorer and Ranger vehicles equipped with 2.3L engines. The fuel line may be loose due to improper tightening of the fuel line…
Ford Motor Company (Ford) is recalling certain 2022 F-150 vehicles. The right-side instrument panel cover may have been manufactured incorrectly, which can cause the air bag to not deploy…
Ford Motor Company (Ford) is recalling certain 2022-2023 Bronco Sport and 2022 F-150 vehicles. The parking lights may flicker when the headlights are activated. As such, these vehicles fail…
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2021-2022 Audi Q3 vehicles. The vent pipe within the fuel tank may have been damaged during fuel tank assembly.
Ford Motor Company (Ford) is recalling certain 2022 F-150 Raptor Series vehicles equipped with 37-inch tires. The lug nuts on the wheels may have been incorrectly tightened.
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston…
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result…
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston…
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error…
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error…
Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result…
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.
The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to this…
Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first…
Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result…
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.