Class IOngoingZ-1526-2025
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271…
Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.GAApr 23, 2025
Recalls in Georgia
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 85–95 of 95 recalls
Class IOngoingZ-1525-2025
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210…
Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.GAApr 23, 2025
Class IOngoingZ-1524-2025
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2201…
Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.GAApr 23, 2025
Class IOngoingZ-1523-2025
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2008…
Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.GAApr 23, 2025
Class IOngoingZ-1522-2025
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210…
Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.GAApr 23, 2025
Class IOngoingZ-1521-2025
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198…
Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.GAApr 23, 2025
Class IIOngoingZ-1427-2025
St. Jude Medical recalls CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Mode…
Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient in…
St. Jude MedicalGAApr 2, 2025
Class IIOngoingZ-1162-2025
Elekta, Inc. recalls MOSAIQ Oncology Information System
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Elekta, Inc.GAFeb 19, 2025
Class IIOngoingZ-0989-2025
St. Jude Medical recalls CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics…
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
St. Jude MedicalGAJan 29, 2025
Class IIOngoingZ-0988-2025
St. Jude Medical recalls CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics S…
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
St. Jude MedicalGAJan 29, 2025
Class IIOngoingZ-0987-2025
St. Jude Medical recalls Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Wh…
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
St. Jude MedicalGAJan 29, 2025