The latest headlines across every section, pulled from official and open-access sources.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. — Golden State Medical Supply Inc. · Class III · Ongoing
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus. — Wisconsin Pharmacal Company · Class I · Ongoing
Lack of Assurance of Sterility — UCB Biosciences Inc. · Class II · Ongoing
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. — Amerisource Health Services LLC · Class III · Ongoing
Defective Container; packets were found to be either empty or partially full. — ANI Pharmaceuticals, Inc. · Class II · Ongoing
Failed Impurities/Degradation Specifications — Sagent Pharmaceuticals · Class III · Ongoing
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. — Lannett Company Inc. · Class III · Ongoing
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. — Haleon US Holdings LLC · Class II · Ongoing
Presence of a Foreign Substance; black particles observed in liquid — Safecor Health, LLC · Class II · Ongoing
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. — Becton, Dickinson and Company · Class II · Ongoing
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and display… — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
Certain lots of product have the potential for a sterile barrier breach. — Medtronic Perfusion Systems · Class II · Ongoing
Certain lots of product have the potential for a sterile barrier breach. — Medtronic Perfusion Systems · Class II · Ongoing
Certain lots of product have the potential for a sterile barrier breach. — Medtronic Perfusion Systems · Class II · Ongoing
Certain lots of product have the potential for a sterile barrier breach. — Medtronic Perfusion Systems · Class II · Ongoing
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. — Becton, Dickinson and Company · Class II · Ongoing
Certain lots of product have the potential for a sterile barrier breach. — Medtronic Perfusion Systems · Class II · Ongoing
Certain lots of product have the potential for a sterile barrier breach. — Medtronic Perfusion Systems · Class II · Ongoing
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module. — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant. — Novapproach Spine, LLC · Class II · Ongoing
Due to stain present on the surface of affected foley catheters. — C.R. Bard Inc · Class II · Ongoing
Affected devices exhibited fractures at the distal shaft tip without complete detachment. — TANGENT ENDOSCOPY, LLC · Class II · Ongoing
Certain lots of product have the potential for a sterile barrier breach. — Medtronic Perfusion Systems · Class II · Ongoing
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and display… — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing