Complete FDA and NHTSA recall records dated in November 2023.
These records include useful source details for the selected month.
Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient…
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4…
There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on…
Undeclared allergen; egg
Undeclared allergen; egg
Undeclared allergen; egg
Undeclared allergen; egg
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Failed Impurities/Degradation Specifications.
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Failed Impurities/Degradation Specifications.
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Tesla, Inc. (Tesla) is recalling certain 2021-2024 Model S and Model X vehicles. An incorrect air bag may have been installed when the steering yoke or round steering wheel was replaced…
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based…
Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and…
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with…
Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and…
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.
