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.
28,992 detailed records are currently available in this category.
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Possible presence of foreign material (rust).
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low.
Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient…
Premature bucket failures
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal…
Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no…
The pouch label was missing the use by date (UBD) of 2018-04.
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
Possible presence of foreign material (rust).
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface…
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
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.
