All recalls8,490 total
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Products may not have received adequate sterilization processing.
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.
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.
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.
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.
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