All recalls7,877 total
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
Salmonella Contamination. Firm detected salmonella on one batch of our SunBiotics Oat Milk Chocolate Covered Almonds.
Undeclared allergen: Hazelnut due to mispackaging. Product with hazelnuts was put in the Artisan Style 1/2 loaf bags. Bags do not have allergen statement that includes hazelnuts.
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Cannulated fenestrated polyaxial screws may be incorrectly labeled
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Devices may possess a programming error resulting in an incorrect device configuration.
Devices may possess a programming error resulting in an incorrect device configuration.
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Cannulated fenestrated polyaxial screws may be incorrectly labeled
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Devices may possess a programming error resulting in an incorrect device configuration.
Potential for temporary loss of imaging (X-ray) functionality due to software issue.
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.