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.
28,065 detailed records are currently available in this category.
BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results…
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet…
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants…
Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Customer reports of the device handset continuing to operate after release of the activation button.
Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
The recall was initiated as a result of the detection of an incorrect nut used in manufacturing.
Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly…
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet…
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Improperly rated fuses were used in the manufacture of the device.
The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
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.
