Complete FDA and NHTSA recall records dated in August 2022.
These records include useful source details for the selected month.
The product falls apart during handling after removal from its primary packaging.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not…
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to…
Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.
Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient…
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
Undeclared allergens; wheat and soy.
Detectable levels of Per- and polyfluoroalkyl substances (PFAS).
The firm was notified by their rice supplier that the product may contain small pieces of glass.
Undeclared allergens; fish and shellfish
The firm was notified by their rice supplier that the product may contain small pieces of glass.
Undeclared wheat
Firm's internal sampling identified a positive Salmonella result on Item 00113 that was on hand at the firm on 7/15/2022. Firm elected to hold all inventory between the sanitation break…
Undeclared allergens; fish, shellfish, egg, and wheat
Undeclared allergens; fish, shellfish, egg, wheat, and soy
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled…
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.
