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.
23,781 detailed records are currently available in this category.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional…
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result…
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional…
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional…
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.
