Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 23341–23360 of 38,428 recalls
Recalled Item: Dimension Aspartate Aminotransferase (AST) assay (Product Number:...
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Salicylate (SAL) reagent chemistry assay
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens...
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Ammonia (AMM) assay
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Creatine Kinase MB (MBI) assay
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Aspartate Aminotransferase (AST) assay
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr:
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Glucose (GLU) assay
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr:...
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Alanine Aminotransferase (ALTI) assay
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Alanine Aminotransferase (ALTI) assay
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ¿ cobas c 6000 MODULAR Series System e
The Issue: Roche has confirmed that a possible sample mismatch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spine Instrumentation
The Issue: for Spinal Clamps to be damaged when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spine Instrumentation
The Issue: for Spinal Clamps to be damaged when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spine Instrumentation
The Issue: for Spinal Clamps to be damaged when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spine Instrumentation
The Issue: for Spinal Clamps to be damaged when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spine Instrumentation
The Issue: for Spinal Clamps to be damaged when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM
The Issue: The instruments are not able to pass instrument
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.