💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
All Recalls
95,089 total recalls in our database
💊 Drugs Class I - Dangerous
STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.
💊 Drugs Class I - Dangerous
Failed pH Specifications
💊 Drugs Class I - Dangerous
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Staar Surgical Company
🏥 Medical Devices Class I - Dangerous
Their is a potential that intraocular implant devices may not meet specifications.
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Integra LifeSciences
🏥 Medical Devices Class I - Dangerous
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
🏥 Medical Devices Class I - Dangerous
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
🏥 Medical Devices Class I - Dangerous
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Wilson-Cook Medical
🏥 Medical Devices Class I - Dangerous
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
🏥 Medical Devices Class I - Dangerous
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
Wilson-Cook Medical
🏥 Medical Devices Class I - Dangerous
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
🏥 Medical Devices Class I - Dangerous
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Staar Surgical Company
🏥 Medical Devices Class I - Dangerous
Their is a potential that intraocular implant devices may not meet specifications.
Stay Safe Cap
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
Updating the labeling to include additional warnings and contraindications for potential side effects.
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Staar Surgical Company
🏥 Medical Devices Class I - Dangerous
Their is a potential that intraocular implant devices may not meet specifications.
DRX Revolution Mobile X-Ray System
Carestream Health
🏥 Medical Devices Class I - Dangerous
Unexpected failure of electrical components within the CPI generator.
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
Integra LifeSciences
🏥 Medical Devices Class I - Dangerous
Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Atrium Medical
🏥 Medical Devices Class I - Dangerous
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Stryker Medical Division of Stryker
🏥 Medical Devices Class I - Dangerous
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.