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 27361–27380 of 38,428 recalls
Recalled Item: Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA
The Issue: Incorrect color coding and attachment reference were included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON SC2000 Ultrasound imaging system with software version VB10C and
The Issue: While imaging with a transesophageal (TEE) transducer (Z6Ms,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Small Bowel Scope Gastrointestinal Tract. This anatomy includes
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signmoidoscope Product Usage: Intended to provide optical visualization of
The Issue: Pentax Medical Video Processor EPK-i5010 has been shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Colonoscope Product Usage: Intended to provide optical visualization of and
The Issue: Pentax Medical Video Processor EPK-i5010 has been shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound Gastroscope Product Usage: Intended to provide optical...
The Issue: Pentax Medical Video Processor EPK-i5010 has been shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gastroscope Product Usage: Intended to provide optical visualization of and
The Issue: Pentax Medical Video Processor EPK-i5010 has been shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Duodenoscope Product Usage: Intended to provide optical visualization of and
The Issue: Pentax Medical Video Processor EPK-i5010 has been shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Confocal GI Scope Product Usage: Intended to provide optical visualization
The Issue: Pentax Medical Video Processor EPK-i5010 has been shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signmoidoscope Intended to provide optical visualization of
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bronchoscope Intended to provide optical visualization of and therapeutic access
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Colonoscope Intended to provide optical visualization of and therapeutic access
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intubation Scope Intended to provide optical visualization of
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laryngo Stroboscope Product Usage Intended to provide optical visualization of
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound Bronchoscope Intended to provide optical visualization of
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound Gastroscope Intended to provide optical visualization of
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Esophagoscope Gastrointestinal Tract. This anatomy includes
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ureteroscope Intended to provide optical visualization of and therapeutic access
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cystoscope Intended to provide optical visualization of and therapeutic access
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Choledocho-Nephroscope Intended to provide optical visualization of and...
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.