Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
NOX MEDICAL
Class I - Dangerous
Error in the device firmware results in the inaccurate detection of device position.
Class I - Dangerous
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Class I - Dangerous
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Medtronic Perfusion Systems
Class I - Dangerous
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Flower Orthopedics
Class I - Dangerous
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
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.
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
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
The devices malfunction under specific operator workflows.
Class I - Dangerous
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
ARCH Leg Positioning System
Innovative Orthopedic Technologies
Class I - Dangerous
Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
WOM World of Medicine AG
Class I - Dangerous
When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.
Class I - Dangerous
Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment used at consignee user facilities. New instructions were not sent to all consignees of the devices at the time of the revision.
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Class I - Dangerous
The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emission of sparks.
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
Class I - Dangerous
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.