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 4801–4820 of 38,428 recalls
Recalled Item: Nanoplasty 3D Bunion Correction System Implant
The Issue: issue causing a higher frequency of interference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: paraPAC plus 310 ventilator kit with internal PEEP and CPAP
The Issue: Smiths Medical became aware of an issue related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: paraPAC 300 ventilator kit without internal PEEP and CPAP
The Issue: Smiths Medical became aware of an issue related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP
The Issue: There is a potential for inadvertent tidal volume
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pneupac paraPAC plus 300 ventilator kit
The Issue: There is a potential for inadvertent tidal volume
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MIC-KEY* Gastric-Jejunal Feeding Tube Kit
The Issue: The IFU was missing some risk information requested
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soltive Premium SuperPulsed Laser System
The Issue: Difficulties in pairing the wireless footswitch with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soltive Pro SuperPulsed Laser System
The Issue: Difficulties in pairing the wireless footswitch with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soltive SuperPulsed Laser System Wireless Footswitch
The Issue: Difficulties in pairing the wireless footswitch with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX
The Issue: Issue with analyzer when the pH of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella CP with SmartAssist
The Issue: Nine (9) Impella CP pumps failed inspection and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for
The Issue: There were 27 complaints between March 22, 2024,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL Powerheart G5 AED
The Issue: G5 Semi-Automatic AED is shipped, with a protective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed
The Issue: There were 27 complaints between March 22, 2024,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Vertix MD - The Vertix MD Trauma has been
The Issue: Short circuit in the power supply unit (PSU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MULTIX TOP - Intended Use: The Multix TOP I PRO
The Issue: Short circuit in the power supply unit (PSU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM MULTIX MP - Inended Radiographic X ray Table is
The Issue: Short circuit in the power supply unit (PSU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MULTIX TOP - Intended Use: The Multix TOP I PRO
The Issue: Short circuit in the power supply unit (PSU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM MULTIX MP - Intended Radiographic X ray Table is
The Issue: Short circuit in the power supply unit (PSU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.