🏥 Medical Devices Class I - Dangerous
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
MEDLINE INDUSTRIES
7 recalls • • Categories: Other Medical Devices, Other Drugs, Surgical Instruments
🏥 Medical Devices Class I - Dangerous
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
🏥 Medical Devices Class I - Dangerous
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
🏥 Medical Devices Class I - Dangerous
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
🏥 Medical Devices Class I - Dangerous
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
🏥 Medical Devices Class I - Dangerous
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
🏥 Medical Devices Class I - Dangerous
There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.
🏥 Medical Devices Class I - Dangerous
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
🏥 Medical Devices Class I - Dangerous
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
🏥 Medical Devices Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
🏥 Medical Devices Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
🏥 Medical Devices Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
🏥 Medical Devices Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
🏥 Medical Devices Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
🏥 Medical Devices Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
🏥 Medical Devices Class I - Dangerous
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
🏥 Medical Devices Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
🏥 Medical Devices Class I - Dangerous
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
🏥 Medical Devices Class I - Dangerous
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
🏥 Medical Devices Class I - Dangerous
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
🏥 Medical Devices Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
🏥 Medical Devices Class I - Dangerous
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
🏥 Medical Devices Class I - Dangerous
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
🏥 Medical Devices Class I - Dangerous
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
🏥 Medical Devices Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
🏥 Medical Devices Class I - Dangerous
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
🏥 Medical Devices Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
🏥 Medical Devices Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
🏥 Medical Devices Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
🏥 Medical Devices Class I - Dangerous
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
💊 Drugs Class I - Dangerous
Subpotent Drug
🏥 Medical Devices Class I - Dangerous
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
🏥 Medical Devices Class I - Dangerous
Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
🏥 Medical Devices Class I - Dangerous
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
🏥 Medical Devices Class I - Dangerous
Convenience kits labeled as sterile have not gone through the sterilization process.
🏥 Medical Devices Class I - Dangerous
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
🏥 Medical Devices Class I - Dangerous
The kits contain certain lots of cannula products where the catheter may not retain its shape.
🏥 Medical Devices Class I - Dangerous
Convenience kits labeled as sterile have not gone through the sterilization process.
🏥 Medical Devices Class I - Dangerous
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
🏥 Medical Devices Class I - Dangerous
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
💊 Drugs Class I - Dangerous
Subpotent drug
🏥 Medical Devices Class I - Dangerous
Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit
💊 Drugs Class I - Dangerous
Defective Container: Customer complaints for leaking bottles and dispensing issues.
🏥 Medical Devices Class I - Dangerous
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
🏥 Medical Devices Class I - Dangerous
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
🏥 Medical Devices Class I - Dangerous
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
🏥 Medical Devices Class I - Dangerous
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
🏥 Medical Devices Class I - Dangerous
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
🏥 Medical Devices Class I - Dangerous
The kits may contain an expired component.
🏥 Medical Devices Class I - Dangerous
The kits may contain an expired component.
🏥 Medical Devices Class I - Dangerous
The kits may contain an expired component.
🏥 Medical Devices Class I - Dangerous
The kits may contain an expired component.
Potential for mold contamination (Aspergillus vadensis)
💊 Drugs Class I - Dangerous
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
🏥 Medical Devices Class I - Dangerous
The devices may not meet the minimum required sterility assurance level.
🏥 Medical Devices Class I - Dangerous
Possible false negative or false positive results due to the product being compromised during shipment.
🏥 Medical Devices Class I - Dangerous
Product was compromised during shipment.
🏥 Medical Devices Class I - Dangerous
Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.
🏥 Medical Devices Class I - Dangerous
The cylindrical sponge component is not x-ray detectable.
🏥 Medical Devices Class I - Dangerous
The cylindrical sponge component is not x-ray detectable.
🏥 Medical Devices Class I - Dangerous
The cylindrical sponge component is not x-ray detectable.
🏥 Medical Devices Class I - Dangerous
The cylindrical sponge component is not x-ray detectable.
🏥 Medical Devices Class I - Dangerous
The cylindrical sponge component is not x-ray detectable.
🏥 Medical Devices Class I - Dangerous
RevMedX Trauma Dressing is being recalled due to package seal integrity.
🏥 Medical Devices Class I - Dangerous
Product compromised during shipment.
🏥 Medical Devices Class I - Dangerous
The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
🏥 Medical Devices Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
🏥 Medical Devices Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
🏥 Medical Devices Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
🏥 Medical Devices Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
🏥 Medical Devices Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
🏥 Medical Devices Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
🏥 Medical Devices Class I - Dangerous
There have been reports of the suction catheter coming apart from the device assembly during use.
🏥 Medical Devices Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
🏥 Medical Devices Class I - Dangerous
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
🏥 Medical Devices Class I - Dangerous
Product was shipped with refrigeration (ice) instead of frozen (dry ice).