Tailstorm Health BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL recall — FDA D-0499-2025
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
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.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained…
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Ford Motor Company (Ford) is recalling certain 2021-2023 Bronco, Explorer, Lincoln Aviator, F-250 SD, F-350 SD, F-450 SD, F-550 SD, 2021-2022 Lincoln Navigator, Mustang, F-150, and 2022…
Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in…
Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video…
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous…
Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
Lack of sterility assurance.
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values…
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a…
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red…
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error…
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left…
Browse recent months with enough recall history for useful comparison.