💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
All Recalls
95,102 total recalls in our database
💊 Drugs Class I - Dangerous
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
🏥 Medical Devices Class I - Dangerous
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
Philips Electronics North America
🏥 Medical Devices Class I - Dangerous
If arm is not fastened securely it could fall down.
MEVION S250 Radiation therapy system
Mevion Medical Systems
🏥 Medical Devices Class I - Dangerous
The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
🏥 Medical Devices Class I - Dangerous
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.
Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
Richard Wolf Medical Instruments
🏥 Medical Devices Class I - Dangerous
Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
Richard Wolf Medical Instruments
🏥 Medical Devices Class I - Dangerous
Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Bard Peripheral Vascular
🏥 Medical Devices Class I - Dangerous
Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
🏥 Medical Devices Class I - Dangerous
There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
C.R. Bard
🏥 Medical Devices Class I - Dangerous
Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Toshiba American Medical Systems
🏥 Medical Devices Class I - Dangerous
When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".
🏥 Medical Devices Class I - Dangerous
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
🏥 Medical Devices Class I - Dangerous
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position.
🏥 Medical Devices Class I - Dangerous
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
🏥 Medical Devices Class I - Dangerous
The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.
Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.