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 11001–11020 of 38,428 recalls
Recalled Item: Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw
The Issue: Proximal end of the driver is oversized in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical...
The Issue: Proximal end of the driver is oversized in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU:
The Issue: Proximal end of the driver is oversized in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU:
The Issue: Proximal end of the driver is oversized in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw
The Issue: Proximal end of the driver is oversized in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS CMV IgM
The Issue: Invalid calibrations (out of range high) while using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Fructosamine (Fruc)
The Issue: Siemens Healthcare Diagnostics Inc. has confirmed the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Lithium_2 (LITH_2)
The Issue: Siemens Healthcare Diagnostics Inc. has confirmed the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H)
The Issue: Siemens Healthcare Diagnostics Inc. has confirmed the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Calcium_2 (CA_2)
The Issue: Siemens Healthcare Diagnostics Inc. has confirmed the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultima Activator II Reusable Drive Mechanism
The Issue: for corrosion on the pins of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The DARCO¿ Locking Bone Plate System is designed with rhombus
The Issue: Product was labelled with the incorrect manufacturing and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioPlex 2200 SYPH T PACK Syphilis Total & RPR Reagent Pack
The Issue: Due to current concerns related to COVID-19 vaccine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioPlex 2200 Syphilis Total & RPR Calibrator Set CAL
The Issue: Due to current concerns related to COVID-19 vaccine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The IFU for the Autoclavable Temperature Probes: Part # 453564635891
The Issue: Update to instructions for use regarding the cleaning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brius Patient Specific Brackets (components in a set of custom
The Issue: Pontics, brackets, and customized orthodontic appliances were sold
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Customized Brius Appliances (custom metal orthodontic devices)
The Issue: Pontics, brackets, and customized orthodontic appliances were sold
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brius Pontics (components in a set of custom metal orthodontic devices)
The Issue: Pontics, brackets, and customized orthodontic appliances were sold
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump
The Issue: Units not properly inspected prior to release to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips
The Issue: There is a potential for AED pads to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.