All recalls8,424 total
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Product may be contaminated with Clostridium botulinum.
Unapproved food additive: sassafras bark.
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Crystallization; identified as Buprenorphine free base
The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.
Total Nutrition Inc. of Deer Park, NY is voluntarily expanding its recall of TNVitamins and Doctor's Pride Ultra Potent Complete Green Superfood Moringa Capsules due to the potential to be contaminated with Salmonella. This expansion follows an ongoing supply chain investigation that identified addi
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
The recalled coolers' latch magnet can detach, posing risk of serious injury or death from a choking hazard.
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.
Metal springs in the detachable hinged lid of the insulated bowls can catch fire when used in the microwave, posing a fire hazard.
The recalled children's pajamas violate the mandatory flammability safety standard for children's sleepwear, posing a risk of serious burn injuries or death to children.
The recalled coffeemakers can become clogged, causing hot liquid or steam to build up and be released unexpectedly during use, posing a risk of serious injury from burn hazard.
The drain covers do not bear the required product markings, in violation of the mandatory safety standard under the?Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing risk of serious injury or death from entrapment and drowning hazards. The drain covers also fail to meet safety requirements because they are missing statements regarding the service life of the covers and installation and maintenance instructions.
The recalled dive sticks violate the federal dive sticks ban because they exceeded the compress limit, posing an impalement hazard. In shallow water, children may fall or land on a dive stick, resulting in serious piercing injuries. Facial and eye injuries are also possible when children attempt to retrieve the sticks underwater.
The drive converter sheave can break in certain circumstances, resulting in metal fragments being discharged within the engine compartment and surrounding area, posing impact and injury hazards.
The fan can overheat, posing a risk of serious injury or death from a fire hazard.
The recalled plastic tip restraint kits (also referred to as furniture straps) can break or degrade, posing tip-over and entrapment hazards. Should the defective plastic tip restraints break, consumers could be at risk of serious injuries or death. This is a hidden defect because consumers who purchase and install this product may be under a false sense of security that their furniture is safe from a tip-over incident.
The recalled golf cars' passenger-side brake cable could have been misrouted during assembly. If the cable was misrouted, abnormal wear can occur which can cause the passenger-side cable to break during use, posing a risk of serious injury or death from a crash hazard.
The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of children's throat and become lodged, posing a serious risk of respiratory distress and deadly choking hazard.
The recalled bed rails violate the mandatory standard for adult portable bed rails, because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. The bed rails do not meet structural stability or retention strap requirements, posing a fall hazard. Furthermore, the bed rails' push pins and push pin holes are incorrectly sized, posing a laceration hazard. In addition, the bed rails do not bear the required hazard warning labels.
The recalled dressers are unstable if not anchored to the wall, posing tip-over and entrapment hazards that can result in a risk of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
The recalled Bistro and Bistro Deluxe vehicles have an inaccurate weight capacity certification label. This could result in the vehicle being overloaded, which poses an injury hazard.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Foreign material: small metal pieces
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.