💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
All Recalls
95,025 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
🏥 Medical Devices Class I - Dangerous
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
🏥 Medical Devices Class I - Dangerous
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Ortho-Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.
🏥 Medical Devices Class I - Dangerous
Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
🏥 Medical Devices Class I - Dangerous
individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result
CoolSeal Generator, REF: CSL-200-50
Bolder Surgical
🏥 Medical Devices Class I - Dangerous
A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of unintended energy to the patient.
🏥 Medical Devices Class I - Dangerous
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
🏥 Medical Devices Class I - Dangerous
Kits were labeled with incorrect expiration dates.
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
🏥 Medical Devices Class I - Dangerous
A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical intervention, or a revision surgery.
🏥 Medical Devices Class I - Dangerous
A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Lusys Laboratories
🏥 Medical Devices Class I - Dangerous
COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.
🏥 Medical Devices Class I - Dangerous
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
Philips North America
🏥 Medical Devices Class I - Dangerous
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
🏥 Medical Devices Class I - Dangerous
There are lower than expected MICs for some gram negative species.
🏥 Medical Devices Class I - Dangerous
Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.
🏥 Medical Devices Class I - Dangerous
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
Nextremity Solutions
🏥 Medical Devices Class I - Dangerous
During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision