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 36941–36960 of 38,428 recalls
Recalled Item: Siemens Mobilette Mira
The Issue: There is a risk of lost images during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Digital RID Plate Reader and Software Product Code: AD400
The Issue: If a control ring is marked after reading,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay
The Issue: Ferritin Analytical Sensitivity and Calibrator C Realignment with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay
The Issue: Ferritin Analytical Sensitivity and Calibrator C Realignment with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin
The Issue: Ferritin Analytical Sensitivity and Calibrator C Realignment with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The
The Issue: RADIOMETER became aware that some membranes may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method
The Issue: Siemens Healthcare Diagnostics has confirmed the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Caddy - PedFuse
The Issue: Two sections that are designated for the 8mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens syngo WorkFlow SLR
The Issue: Under certain conditions, when using the Search functionality,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The touchscreen display (model 94267) designed for use with the
The Issue: failure of Spacelabs Healthcare Touchscreen Display, Model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pinnacle3 VCC P/N 4598 001 41341 REV A
The Issue: Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PSX PROXIMATE Skin Staple Extractor
The Issue: Damage to the packaging may have compromised the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BMC RF Cannula Curved Sharp RadiOpaque
The Issue: A report of an event was received indicating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a...
The Issue: The color code on label conflicts with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD CYCLESURE 24 Biological Indicator (BI) product
The Issue: Advanced Sterilization Products (ASP) is recalling all lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150
The Issue: The firm recalled due to higher reactivity with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Repeater Pump
The Issue: The firm is issuing a field correction to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Cardio Imaging 5.0 is a software only Picture Archiving
The Issue: GE Healthcare is aware of a potential safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD
The Issue: BD received a complaint report for mixed syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
The Issue: Broken screw insertor hardness was measured and found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.