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 5921–5940 of 38,428 recalls
Recalled Item: NaviNetics Skull Anchor Key and Drill Kit
The Issue: Defective Skull Anchor Key. After attachment of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Pressure Unit
The Issue: The firm provided a set of specifications for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The LeadCare¿ II Blood Lead Test System relies on electrochemistry
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation 4000 . Intended to securely store
The Issue: Retroactive-Due to increase in complaints, their is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation Auxiliary 4000 . Intended to securely
The Issue: Retroactive-Due to increase in complaints, their is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation ES (Med ES Main) . Intended
The Issue: Retroactive-Due to increase in complaints, their is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation Auxiliary ES . Intended to securely
The Issue: Retroactive-Due to increase in complaints, their is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON Redwood 1.0 Diagnostic Ultrasound System
The Issue: On ultrasound systems, when Cardiac DICOM SR feature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON Maple Diagnostic Ultrasound System
The Issue: On ultrasound systems, when Cardiac DICOM SR feature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON Juniper Diagnostic Ultrasound System
The Issue: On ultrasound systems, when Cardiac DICOM SR feature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Altair 330 lbs w/o Hanger Bar
The Issue: Patient lift hanger bar may come loose, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE SWABSTICKS PVP 3 PK
The Issue: Product may have a weak seal which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Software Version Numbers version numbers 8B
The Issue: A use error that has occurred with RayStation/RayPlan,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S
The Issue: Product may have a weak seal which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300)
The Issue: Product may have a weak seal which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion STERILE COTTON DENTAL ROLLS 6/PK
The Issue: Product may have a weak seal which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT
The Issue: Product may have a weak seal which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE M1S0179 STRL TAPE/PEN PACK
The Issue: Product may have a weak seal which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion STERILE #16 RUBBER BAND
The Issue: Product may have a weak seal which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185)
The Issue: Product may have a weak seal which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.