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.
30,447 detailed records are currently available in this category.
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA…
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
Report received where the Align Radial Stem fractured.
Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the use of an alternate method of screw…
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA…
Laser etching on the parts is wider and deeper than the conditions previously validated.
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Laser etching on the parts is wider and deeper than the conditions previously validated.
Potential breach of sterile barrier due to defective product tray.
Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.
Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
Laser etching on the parts is wider and deeper than the conditions previously validated.
Laser etching on the parts is wider and deeper than the conditions previously validated.
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA…
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA…
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Laser etching on the parts is wider and deeper than the conditions previously validated.
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA…
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA…
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
The stem taper on this device is undersized; the gauge point is not deep enough.
Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field.
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
Laser etching on the parts is wider and deeper than the conditions previously validated.
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.
