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 17801–17820 of 38,428 recalls
Recalled Item: AUTION HYBRID AU-4050
The Issue: This correction is being initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica Cryostats
The Issue: The current labelling does not include any specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion MaxPlus Clear Needleless Connector. Intended for Positive...
The Issue: After disconnection of a luer, the valve of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SenTec Standard Starter Set with and without Service Gas (2
The Issue: There is an increased chance (approx. 5%) of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EnCor Breast Biopsy Probes
The Issue: There has been an increase in complaints related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is
The Issue: There is an increased chance (approx. 5%) of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EnCor Breast Biopsy Probes
The Issue: There has been an increase in complaints related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SenTec Neonatal Starter Set with and without Service Gas (2
The Issue: There is an increased chance (approx. 5%) of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SenTec Membrane Changer Set (1 charger plus 1 insert) -
The Issue: There is an increased chance (approx. 5%) of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EnCor Breast Biopsy Probes
The Issue: There has been an increase in complaints related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EnCor Breast Biopsy Probes
The Issue: There has been an increase in complaints related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EnCor Breast Biopsy Probes
The Issue: There has been an increase in complaints related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SenTec Membrane Changer Insert [5 pcs - Product Usage: is
The Issue: There is an increased chance (approx. 5%) of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EnCor Breast Biopsy Probes
The Issue: There has been an increase in complaints related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revive Reusable Bladder Support
The Issue: The product is unable to meet the use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neff Percutaneous Access Set
The Issue: The products may have been manufactured without the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401
The Issue: Table assembly error with incorrect actuators for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical
The Issue: Mixer blade may separate from mixer due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B.Braun Infusomat Space Volumetric Infusion Pump Administration Set
The Issue: for the Infusion Pump Administration Set to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and...
The Issue: The 0-arm 1000 Imaging System uses energy from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.