Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
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…
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…
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…
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
The Internal packaging, the pouch and patient labels are improperly labeled.
Device may display a battery missing error.
Kit was labeled with the incorrect Expiration Date of April 30, 2019.
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…
There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of the patient transfer mechanism that…
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…
Browse recent months with enough recall history for useful comparison.
