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 2901–2920 of 38,428 recalls
Recalled Item: A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO
The Issue: Due to an error message that prevents users
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 35 ECG cable
The Issue: Product shipped with incorrect IFU. IFU does not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel...
The Issue: Internal quality control procedures were not followed correctly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel...
The Issue: Internal quality control procedures were not followed correctly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog
The Issue: Regulatory documentation error and misleading color packaging claim
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M V.A.C. VIA Negative Pressure Wound Therapy System /US
The Issue: Due to increase in complaints related to leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Prevena Plus 125 Therapy Unit and System Kits REF:
The Issue: Due to increase in complaints related to leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated
The Issue: Their is a potential of fluid leakage from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plato 17 Microcatheter To assist in delivery of
The Issue: Due to manufacturing non-conformance that resulted in channels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation- Intended as a Radiation Therapy Treatment Planning
The Issue: Inconsistency in the use of Density uncertainty in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation- Intended as a Radiation Therapy Treatment Planning
The Issue: Inconsistency in the use of Density uncertainty in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation -Intended as a Radiation Therapy Treatment Planning
The Issue: Inconsistency in the use of Density uncertainty in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation- Intended as a Radiation Therapy Treatment Planning
The Issue: Inconsistency in the use of Density uncertainty in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation- Intended as a Radiation Therapy Treatment Planning
The Issue: Inconsistency in the use of Density uncertainty in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.