🏥 Medical Devices 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.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices 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.
🏥 Medical Devices 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.
AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Biodex Medical Systems
🏥 Medical Devices Class I - Dangerous
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration
🏥 Medical Devices Class I - Dangerous
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
🏥 Medical Devices Class I - Dangerous
There is a potential for distal end of catheters to fracture and become detached.
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Atrium Medical
🏥 Medical Devices 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.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
Olympus Corporation of the Americas
🏥 Medical Devices 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
🏥 Medical Devices 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."
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
🏥 Medical Devices Class I - Dangerous
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
🏥 Medical Devices Class I - Dangerous
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
🏥 Medical Devices Class I - Dangerous
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
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
🏥 Medical Devices 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