Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled recall — FDA D-0569-2023
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
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.
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Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
CGMP Deviations
CGMP Deviations
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Ford Motor Company (Ford) is recalling certain 2020-2022 Explorer Police Interceptor Utility vehicles equipped with a 12.1-inch Integrated Computer Screen (ICS). When the Display On/Off…
Chrysler (FCA US, LLC) is recalling certain 2022-2023 Jeep Wrangler Plug-In Hybrid Electric vehicles (PHEV). The high voltage (HV) battery pack assembly was built with incorrect fasteners…
Chrysler (FCA US, LLC) is recalling certain 2019-2021 Ram ProMaster vehicles equipped with a 62TE transmission. The park pawl may not fully engage the park gear due to debris inside the…
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys" after processing has occurred.…
Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm - 60mm; not the correct drill depth range of 10mm - 40mm.
The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results generated…
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass…
A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit…
There have been complaints that the clip did not come out of the tube sheath during the procedure.
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients…
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.
Browse recent months with enough recall history for useful comparison.