Class I - Dangerous
Primary packaging labeling may be incorrect.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
Olympus Corporation of the Americas
Class I - Dangerous
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Shanghai United Imaging Healthcare Co.
Class I - Dangerous
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Class I - Dangerous
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
Olympus Corporation of the Americas
Class I - Dangerous
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Class I - Dangerous
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
Olympus Corporation of the Americas
Class I - Dangerous
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Class I - Dangerous
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.
BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
Olympus Corporation of the Americas
Class I - Dangerous
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Class I - Dangerous
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.
Class I - Dangerous
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Atrium Medical
Class I - Dangerous
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
Class I - Dangerous
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.
BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
Olympus Corporation of the Americas
Class I - Dangerous
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
BF-N20 OES Bronchofiberscope, Model No. BF-N20
Olympus Corporation of the Americas
Class I - Dangerous
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health
Class I - Dangerous
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
Accelerated Care Plus
Class I - Dangerous
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health
BF-P60 OES Bronchofiberscope, Model No. BF-P60
Olympus Corporation of the Americas
Class I - Dangerous
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."