💊 Drugs Class I - Dangerous
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
All Recalls
95,075 total recalls in our database
💊 Drugs Class I - Dangerous
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
💊 Drugs Class I - Dangerous
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
💊 Drugs Class I - Dangerous
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Boothwyn Pharmacy
💊 Drugs Class I - Dangerous
Subpotent Drug
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
B BRAUN MEDICAL
💊 Drugs Class I - Dangerous
Presence of Particulate Matter
Subpotent Drug
Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Boothwyn Pharmacy
💊 Drugs Class I - Dangerous
Subpotent Drug
IDM-MICRO-R. Electrical wheelchair component.
mo-Vis BVBA
🏥 Medical Devices Class I - Dangerous
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
The catheters may not retain their shape.
🏥 Medical Devices Class I - Dangerous
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
🏥 Medical Devices Class I - Dangerous
Due to products distributed without premarket clearance or approvals.
🏥 Medical Devices Class I - Dangerous
The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in the surgical cavity and potentially leading to surgical site infections.
🏥 Medical Devices Class I - Dangerous
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
🏥 Medical Devices Class I - Dangerous
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
🏥 Medical Devices Class I - Dangerous
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
🏥 Medical Devices Class I - Dangerous
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App . The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
🏥 Medical Devices Class I - Dangerous
Packaging failures were identified which could lead to a breach in the sterile barrier.