95,050 total recalls in our database
BEEKEEPER'S NATURALS USA
Microbial Contamination of Non-Sterile Products
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Microbial contamination of sterile products
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Fresenius Kabi USA
Failed Impurities/Degradations Specifications
Presence of Particulate matter: Particulate matter identified as glass.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
INSPIREMD
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
GE Medical Systems
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
Fresenius Medical Care Holdings
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
Avanos Medical
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Avanos Medical
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Avanos Medical
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Avanos Medical
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
INSPIREMD
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.