🏥 Medical Devices Class I - Dangerous
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
All Recalls
95,075 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.
🏥 Medical Devices Class I - Dangerous
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
IntelePACS (Image Fusion Module) - InteleViewer
INTELERAD MEDICAL SYSTEMS INCORPORATED
🏥 Medical Devices Class I - Dangerous
A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.
🏥 Medical Devices Class I - Dangerous
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
🏥 Medical Devices Class I - Dangerous
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
Ventec Life Systems
🏥 Medical Devices Class I - Dangerous
Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.
🏥 Medical Devices Class I - Dangerous
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
SIGNA MR380, NMRI system, Non-US Only
GE Healthcare (China) Co.
🏥 Medical Devices Class I - Dangerous
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Physio-Control
🏥 Medical Devices Class I - Dangerous
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
Optima MR360, NMRI system
GE Healthcare (China) Co.
🏥 Medical Devices Class I - Dangerous
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
🏥 Medical Devices Class I - Dangerous
Due to fingerprint scanner failing resulting in the scanner heating up.
🏥 Medical Devices Class I - Dangerous
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
🏥 Medical Devices Class I - Dangerous
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
🏥 Medical Devices Class I - Dangerous
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
ARVA Neo BT Pro Avalanche Transceivers
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
A fuse within the avalanche transceiver can be defective and cause power to drain from the battery, posing a risk of loss of emergency communication which could result in serious injury or death.
Canyon Speedmax CF Triathlon Bicycles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The aerostem fork steerer tube on the recalled bicycles can crack or break, posing fall and injury hazard.
Babyjoy High Chairs
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The recalled high chairs pose a fatal suffocation risk because they were marketed, intended, or designed for infant sleep, and they have an incline angle greater than 10 degrees in violation of the federal Safe Sleep for Babies Act. In addition, the high chair poses a deadly entrapment hazard because the opening between the seat and tray is large enough that a child can become entrapped in it, which is a violation of the federal regulations for high chairs.
Forever 21 Children's Pajamas
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The recalled pajamas violate the flammability regulations for children's sleepwear, posing a risk of burn injuries to children.
Goal Zero Solar Series Combiner Cables for Solar Panels
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The recalled combiner cables can malfunction when used with Nomad-series solar panels, posing a fire hazard.