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.
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in…
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic…
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This…
ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection…
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic…
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic…
ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection…
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic…
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic…
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in…
Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems.
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in…
Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection…
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic…
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic…
Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the zero reference with respect to other Access ClearVue Prone Breast devices. This can result…
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic…
Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems.
Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device during system maintenance. The…
Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices.…
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in…
ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection…
Specific CDI Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature value that…
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.
