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 14421–14440 of 38,428 recalls
Recalled Item: PROFEMUR Neck Long Titanium
The Issue: MicroPort Orthopedics Inc. states that there have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROFEMUR Neck Extra Long Titanium
The Issue: MicroPort Orthopedics Inc. states that there have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROFEMUR Titanium and Cobalt Chrome modular necks
The Issue: MicroPort Orthopedics Inc. is voluntarily recalling any existing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Klarity Vacuum Bags
The Issue: Vacuum bags potentially may not hold their vacuum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EL-Anti-SARS-CoV-2 IgM Kit
The Issue: Device did not meet the updated EUA packet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CME America T-Syringe Pump - T34 - Product Usage: infusion
The Issue: Multiple reasons: 1) Due to wear and tear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CME America T-Syringe Pump - T34L PCA - Product Usage:
The Issue: Multiple reasons: 1) Due to wear and tear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CME America T-Syringe Pump - Neofeed - Product Usage: infusion
The Issue: Multiple reasons: 1) Due to wear and tear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CME America T-Syringe Pump - Ameritus 1st Enteral Pump -
The Issue: Multiple reasons: 1) Due to wear and tear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CME America T-Syringe Pump - NeoThrive - Product Usage: infusion
The Issue: Multiple reasons: 1) Due to wear and tear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CME America T-Syringe Pump -T34L - Product Usage: infusion of
The Issue: Multiple reasons: 1) Due to wear and tear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm
The Issue: Universa Soft Ureteral Stent Sets were incorrectly placed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KIT
The Issue: Only providing one nasal swab in our pre-operative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AM1054 Randox Ammonia (NH3)
The Issue: Randox Ammonia reagents are being recalled from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AM1015 Randox Ammonia (NH3)
The Issue: Randox Ammonia reagents are being recalled from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cios Spin
The Issue: Siemens has become aware of a hardware error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cios Alpha
The Issue: Siemens has become aware of a hardware error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perceval Single Use Accessory Kit
The Issue: LivaNova received complaints indicating the impossibility to collapse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perceval Single Use Accessory Kit
The Issue: LivaNova received complaints indicating the impossibility to collapse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perceval Dual Collapser
The Issue: LivaNova received complaints indicating the impossibility to collapse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.