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.
27,577 detailed records are currently available in this category.
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled,…
The 30 minute maximum tanning time has been reduced to 20 minutes.
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom…
The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified…
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Potential for leak test failures.
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be…
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be…
Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match the…
Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive…
Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be…
Device was distributed with the etching missing from the product.
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be…
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be…
Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be…
Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the…
Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manufactured by BD, sold in Centurion Convenience Kits. distributed between May 2016 and June…
Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the…
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be…
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be…
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.
