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.
24,725 detailed records are currently available in this category.
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail…
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the…
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an…
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee…
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the…
Product was distributed without receiving regulatory clearance.
Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may…
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail…
The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD,…
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee…
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the…
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee…
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the…
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the…
An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the…
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the…
The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the…
The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
The tube holder can separate from the barrier that secures the device to the patients' body. The tube holder has the potential failure to separate from the barrier. This separation might…
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail…
Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300…
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the…
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.
