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.
29,496 detailed records are currently available in this category.
Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.
Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where…
One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The…
Potential for the female luer component of the InVision-Plus IV connector to crack during use.
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue…
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may…
Potential for the female luer component of the InVision-Plus IV connector to crack during use.
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer.
The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner.
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The…
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
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.
