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 26641–26660 of 38,428 recalls
Recalled Item: cobas p 471 centrifuge unit calculator/data processing module
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas p 701 Post-Analytical Unit calculator/data processing module
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VS II Aliquoter System calculator/data processing module
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RSD 800 Sorting System calculator/data processing module
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas p 501 Post-Analytical Unit calculator/data processing module
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas p 512 Pre-Analytical Instrument calculator/data processing module
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas p 612 Pre-Analytical Instrument calculator/data processing module
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RSD 800A Aliquoting System calculator/data processing module
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas 6000 Series system c6000
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas 8000 Modular Analyzer Series c8000
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas p 312 Pre-Analytical System calculator/data processing module
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage:
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoscopic Articulating Linear Cutter
The Issue: Quality control identified a component issue where the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoscopic Articulating Linear Cutter
The Issue: Quality control identified a component issue where the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affinity Four Birthing Bed Model P3700 The primary packaging is Recalled by...
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The
The Issue: Topcon discovered an anomaly with titration, only when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.