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.
27,110 detailed records are currently available in this category.
There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.
The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating…
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur…
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur…
A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected…
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for…
The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting…
The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting…
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by…
When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health…
The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating…
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur…
Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst.
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by…
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by…
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for…
The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur…
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur…
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur…
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure.…
Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure.…
The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure.…
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.
