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 6981–7000 of 38,428 recalls
Recalled Item: Philips Affiniti 70
The Issue: Their is the potential that diagnostic ultrasound systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200)
The Issue: Their is the potential that diagnostic ultrasound systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MED-810A Zemits NDPrime Laser products
The Issue: Advance-Esthetic LLC failed to comply with the applicable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D-Clip Standard/Mini Applier
The Issue: Customer complaint received that reported the applier failed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D-Clip Standard/Mini Applier
The Issue: Customer complaint received that reported the applier failed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D-Clip Standard/Mini Applier
The Issue: Customer complaint received that reported the applier failed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Da Vinci Single-Site Wristed Needle Driver
The Issue: There is the potential for the needle drive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORION System with software OSS v6.0 and OSS v7.0- An
The Issue: Users of the patient positioning system ORION System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORION System with software OSS v6.0 and OSS v7.0- An
The Issue: Users of the patient positioning system ORION System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONTRA GRAY (soft) TURBO PLUS CUPS
The Issue: one lot of Contra Gray (soft) Turbo Plus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDFLEX
The Issue: If "Clear All" selected medications is selected on
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: Reverse Shoulder System e+
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CereLink ICP Extension Cable (Extension Cable)
The Issue: Firm is expanding the existing recall RES 90457
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mobilett Mira wireless (VA20) mobile x-ray system(s)
The Issue: Due to the incorrect mounting of the buzzer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Uric Acid Monitoring System Each kit contains 1 meter
The Issue: Due to products distributed without premarket clearance or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Uric Acid Monitoring System Each kit contains 1 meter
The Issue: Due to products distributed without premarket clearance or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DENTEMP ONE STEP .077OZ
The Issue: Products were stored outside of labeled temperature requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Insyte Autoguard BC Shielded IV Catheter with Blood Control
The Issue: Over-the-needle, intravascular catheters may have needles that do
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acumen IQ Sensor with VAMP System
The Issue: Their is the potential for flushing difficulties during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.