Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.
3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on…
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as…
There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk…
Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before…
1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the…
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip…
The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk…
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for…
Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned…
VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as…
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip…
Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized…
Browse recent months with enough recall history for useful comparison.
