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 12301–12320 of 38,428 recalls
Recalled Item: Palindrome RT Chronic Catheter Kit Symmetrical Tip
The Issue: This voluntary withdrawal is being conducted to implement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip
The Issue: This voluntary withdrawal is being conducted to implement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome RT Repair Kit 15 FR TAL 28cm
The Issue: This voluntary withdrawal is being conducted to implement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affinity Four Birthing Bed-used as a birthing bed for women
The Issue: Latch mechanism on the Lift-Off foot section of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare
The Issue: The pump has an impeller with a shroud
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component)
The Issue: Two lots have been swapped thus have the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte
The Issue: May show unexpected locus specific signals in addition
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nail Insertion Sleeve
The Issue: The devices have a different inner diameter than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Straumann SCS Screwdriver
The Issue: Tip of the screwdriver does not have the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nail Insertion Sleeve
The Issue: The devices have a different inner diameter than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cell Marque Antibodies
The Issue: Product distributed for use as an In-vitro Diagnostics
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60
The Issue: Telepack may not power on when using the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cell Marque
The Issue: Product distributed for use as an In-vitro Diagnostics
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS pheno- angiography systems developed for single and biplane diagnostic
The Issue: Software error VE10B -In case of a fault
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion systems with software release R1.x
The Issue: In the Azurion system, the user can add
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion systems with software release R2.0.x
The Issue: In the Azurion system, the user can add
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235-Proton Therapy System
The Issue: if the user forgets to select the trigger
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unifine Pentips Plus
The Issue: Mixed Up. Two (2) cases of Unifine Pentips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit
The Issue: There is a potential that the pressure tubing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards TruWave 3 cc/VAMP Jr Kit
The Issue: There is a potential that the pressure tubing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.