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 18341–18360 of 38,428 recalls
Recalled Item: BD Veritor System Reader -In Vitro Diagnostic for use with
The Issue: Background calibration has the potential to cause false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with
The Issue: Background calibration has the potential to cause false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance
The Issue: There is no warning in the Elekta Unity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G-6-PDH Normal Control (G-6-PDH CONTROL N)
The Issue: The target values and ranges in these lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G-6-PDH Deficient Control (G-6-PDH CONTROL D)
The Issue: The target values and ranges in these lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maestro Orthodontic Bracket QTY. 20 Rx Only (01)00190707017064 (10)889437
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maestro Orthodontic Bracket QTY. 10 Rx Only (01)00190707016517 (10)112233
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath
The Issue: Product may have been assembled incorrectly,the assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP
The Issue: Product may have been assembled incorrectly,the assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP
The Issue: Product may have been assembled incorrectly,the assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP
The Issue: Product may have been assembled incorrectly,the assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath
The Issue: Product may have been assembled incorrectly,the assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath
The Issue: Product may have been assembled incorrectly,the assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath
The Issue: Product may have been assembled incorrectly,the assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath
The Issue: Product may have been assembled incorrectly,the assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L
The Issue: Product may have been assembled incorrectly,the assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci SP surgical system
The Issue: Intuitive has become aware that the da Vinci
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus MAJ-209 Single Use Suction Valves
The Issue: There is a potential for the single use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mobi-C 14mm Distraction Screw
The Issue: Incorrect part description contained on an additional label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH LASERTUBE (Rubber)
The Issue: The firm received reports indicating that the laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.