Complete FDA and NHTSA recall records dated in 2018, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Failed Tablet/Capsule Specifications: Tablet breakage
Failed Stability Specifications: lot out of specification for elevated water vapor.
Failed Tablet/Capsule Specifications: Tablet breakage
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Failed Dissolution Specifications
Carcinogen impurity detected in API used to manufacture drug product.
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Subaru of America, Inc. (Subaru) is recalling certain 2019 Subaru Ascent vehicles. These vehicles may be missing spot welds on, or around, the B-Pillar, compromising vehicle strength.
Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting in incorrect patient…
Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up…
The connector of the power supply was capable of fitting other components provided with the system. However, the voltage output of the reader power supply is incompatible with the other…
The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had…
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging…
Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.
Discrepant results have been reported in patients with severe microcytic anemia (e.g.iron deficiency, thalassemia) and the following parameters are affected: RBC (red blood cell count), HGB…
Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.
The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners…
Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an…
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
