The latest headlines across every section, pulled from official and open-access sources.
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
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
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, care… — ICU Medical, Inc. · 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
Product was made with milk powder recalled by the supplier due to Salmonella contamination. — PS Seasoning & Spices, Inc. · Class I · Ongoing
potential presence of Salmonella — JOHN B SANFILIPPO & SONS INC · Class I · Ongoing
Potential contamination with Salmonella. — Ghirardelli Chocolate Company · Class I · Ongoing
May be under-processed resulting in growth of Clostridium botulinum and lists health claims. — LIQUID BLENZ CORP · Class II · Ongoing
potential to be contaminated with Salmonella — Solina U.S. Holding · Class I · Ongoing
Product was made with milk powder recalled by the supplier due to Salmonella contamination. — Fontana Flavors, Inc · Class I · Ongoing
potential presence of Salmonella — JOHN B SANFILIPPO & SONS INC · Class I · Ongoing
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. — Wellnov Supplements LLC · Class II · Completed
potential to be contaminated with Salmonella — Solina U.S. Holding · Class I · Ongoing
Product was made with milk powder recalled by the supplier due to Salmonella contamination. — PS Seasoning & Spices, Inc. · Class I · Ongoing