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.
22,877 detailed records are currently available in this category.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
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…
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…
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…
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…
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…
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.
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…
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…
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.
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.
There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.
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…
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
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 saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
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.
