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 22241–22260 of 38,428 recalls
Recalled Item: Sonimage HS1 Ultrasound Kit AC adapter
The Issue: There is a risk of circuit board breakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sonimage HS1 Ultrasound Kit AC adapter
The Issue: There is a risk of circuit board breakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORT-A-CATH II PS/Titan
The Issue: Certain models and lots of PORT A CATH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power PORT-A-CATH II
The Issue: Certain models and lots of PORT A CATH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultra Renew Plus
The Issue: Distribution of medical devices with unapproved green LED
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultra Renew
The Issue: Distribution of medical devices with unapproved green LED
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Truth Renew Plus
The Issue: Distribution of medical devices with unapproved green LED
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 20e DEFIBRILLATOR/MONITOR
The Issue: Physio-Control is aware that some devices have had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volumat MC Agilia Volumetric Infusion Pump
The Issue: Fresenius Kabi initiated a mandatory software upgrade of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VNS(R) Therapy Programmer
The Issue: Two Model 3000 Programmers were distributed in error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sundream 12 V tanning bed
The Issue: The 30 minute maximum tanning time has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEKTA Digital Accelerator under the following brand names: Elekta Synergy
The Issue: There is a potential for an uncontrolled extension
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee...
The Issue: Incorrect product and/or label. Sizing is labeled incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rotating IV Pole Rotating IV Pole falls under the category
The Issue: There is the potential for the Rotating IV
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gas Module 3 monitoring spirometer
The Issue: The firm made multiple changes to the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BCI Advisor Vital Signs Monitor
The Issue: Some printing modes on the devices may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona Partial Knee spacer block instruments
The Issue: Certain partial knee implant spacer blocks do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tapered Screw-Vent MTX
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tapered Screw-Vent MTX
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.