Complete FDA and NHTSA recall records dated in July 2024.
These records include useful source details for the selected month.
The firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food…
Subpotent Drug: reduced efficacy for epinephrine
Cross contamination with other products
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
CGMP Deviations
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Cross contamination with other products
Cross contamination with other products.
Cross contamination with other products.
BMW of North America, LLC (BMW) is recalling certain 2018-2023 X3 sDrive30i, X3 xDrive30i, X3 M40i, and X3 M vehicles. The attachment for the interior cargo rail may become damaged in a…
Hyundai Motor America (Hyundai) is recalling certain 2024 Santa Fe vehicles. A software error in the transmission control unit may result in a vehicle roll away when the vehicle is in PARK.
One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot…
Potential for inaccurate fetal heart rate measurements when monitoring multiples.
Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac…
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release…
HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configuration of the modular Instrument removed the primary light source and the excitation…
The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during…
Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
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.
