Recall category
Devices a patient or caregiver can identify as used, worn, implanted, or supplied for their care.
Due to incorrect shelf-life expiration date.
Missing from associated official evidence: action.
Temperature probe devices lack FDA clearance.
Missing from associated official evidence: action, consumer scope.
Due to customer complaint regarding incorrect display box labeling.
Missing from associated official evidence: action, consumer scope.
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.
Missing from associated official evidence: action, consumer scope.
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to th...
Missing from associated official evidence: action, consumer scope.
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand...
Missing from associated official evidence: action, consumer scope.
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap m...
Missing from associated official evidence: action, consumer scope.
Some of the Calibration/Output Certificates had the outputs reversed.
Missing from associated official evidence: action, consumer scope.
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspe...
Missing from associated official evidence: action, consumer scope.
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received ser...
Missing from associated official evidence: action, consumer scope.
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette a...
Missing from associated official evidence: action, consumer scope.
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is inst...
Missing from associated official evidence: action, consumer scope.
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central...
Missing from associated official evidence: action.
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Missing from associated official evidence: action, consumer scope.
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Missing from associated official evidence: action, consumer scope.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Missing from associated official evidence: action, consumer scope.
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code...
Missing from associated official evidence: action, consumer scope.
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Missing from associated official evidence: action.
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Missing from associated official evidence: action.
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 dr...
Missing from associated official evidence: action, consumer scope.
Certain lots of product have the potential for a sterile barrier breach.
Missing from associated official evidence: action.
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...
Missing from associated official evidence: action, consumer scope.
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...
Missing from associated official evidence: action.
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.
Missing from associated official evidence: action, consumer scope.
