All recalls8,501 total
Incomplete seals on sterile product
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Due to nonconforming products being inadvertently distributed.
Product has the potential to be contaminated with Salmonella.
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Undeclared milk.
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.
Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change.
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).