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 20681–20700 of 38,428 recalls
Recalled Item: Endoscopic Cleaning Brush
The Issue: There is potential risk of brush detachment during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21
The Issue: proplylene glycol contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RT-5100
The Issue: The lens bonding was incomplete on the refractor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient
The Issue: Abbott is advising customers that a small number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VOLISTA StandOP Surgical Light
The Issue: Certain VOLISTA StandOP Surgical Lights have been identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111
The Issue: The data in the National Joint Registry of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JOURNEY BCS OXINIUM Knee Femoral Components
The Issue: The data in the National Joint Registry of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Journey BCS Knee CoCr Femoral Components
The Issue: The data in the National Joint Registry of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica Biosystems HistoCore SPECTRA ST
The Issue: These devices have an incorrect specification against safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S-SPOT
The Issue: There is a potential for imaging artifact to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TomoSPOT
The Issue: There is a potential for imaging artifact to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-SPOT
The Issue: There is a potential for imaging artifact to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arctic Sun Temperature Management System
The Issue: An improper wiring connection on the chiller assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy 100
The Issue: In 2018, Philips Respironics added foam replacement to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive
The Issue: Incorrect use-by date on the device registration/patient file
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2"
The Issue: The incorrect plastic was used to manufacture the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MyLab Gamma
The Issue: The probe power monitoring settings have been found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MyLab Alpha
The Issue: The probe power monitoring settings have been found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MyLab Seven
The Issue: The probe power monitoring settings have been found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nokia BPM+ Wireless Blood Pressure Monitor Product System
The Issue: Device could not meet the requirements for systolic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.