Complete FDA and NHTSA recall records dated in August 2018.
These records include useful source details for the selected month.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Volvo Car USA LLC (Volvo) is recalling certain 2019 Volvo XC40 vehicles. The brake pedals may not have been correctly riveted, allowing the pedal to move out of position, possibly reducing…
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
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.
