🏥 Medical Devices Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
All Recalls
92,900 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
🏥 Medical Devices Class I - Dangerous
Due to incorrect product label (Incorrect product name identified on outer packaging).
🏥 Medical Devices Class I - Dangerous
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
🏥 Medical Devices Class I - Dangerous
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
Medline Industries
🏥 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
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
🏥 Medical Devices Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
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.
MONARCH Bronchoscope. Model Number: MBR-000211-B
Auris Health
🏥 Medical Devices Class I - Dangerous
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
🏥 Medical Devices Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
🏥 Medical Devices Class I - Dangerous
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
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.
When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
🏥 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 STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Medline Industries
🏥 Medical Devices Class I - Dangerous
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.