Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
26,628 detailed records are currently available in this category.
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Devices were delivered without the required dry ice.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Devices were delivered without the required dry ice.
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and…
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
The kits may contain the incorrect number of components or the kits may be missing components.
Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
