Complete FDA and NHTSA recall records dated in July 2021.
These records include useful source details for the selected month.
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
BMW of North America, LLC (BMW) is recalling certain 2021 2 Series (230i, 230i xDrive, M240i, M240i xDrive), 330e, 330e Xdrive, 4 Series Coupe (430i, 430i xDrive, M440i xDrive) M4 Coupe, M4…
Ford Motor Company (Ford) is recalling certain 2021 F-150 vehicles. The electronic brake booster may leak brake fluid into the electronic control unit, which could result in reduced braking…
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of…
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added…
Potential for a false-negative result.
Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking…
Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for handling the product provided to end users.
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of…
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking…
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied…
Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added…
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of…
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
Potential for a false-negative result.
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Potential for a false-negative result.
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the…
Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended…
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.
