All recalls7,799 total
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Failed PH Specifications
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Undeclared hazelnut and soy lecithin.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.
Product has the potential for false positive results
Foreign object (stainless steel dust/flakes or shreds of plastic)
Foreign object (stainless steel dust/flakes or shreds of plastic)
Foreign object (stainless steel dust/flakes or shreds of plastic)
Foreign object (stainless steel dust/flakes or shreds of plastic)
Foreign object (stainless steel dust/flakes or shreds of plastic)
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Potential contamination with foreign materials.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).