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 3421–3440 of 38,428 recalls
Recalled Item: GE Healthcare Optima 520
The Issue: GE HealthCare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Revolution Maxima
The Issue: GE HealthCare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Operator Console Upgrade Types
The Issue: GE HealthCare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Operator Console Upgrade Types
The Issue: GE HealthCare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Operator Console Upgrade Types
The Issue: GE HealthCare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V.A.C. Ulta Therapy Unit & ULTDEV01 The 3M"
The Issue: Due to potential system error alarm and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mammotrak Interventional Coil 3.0T
The Issue: safety issue where a patient may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CI Analyzer. Catalog Numbers: 10947347.
The Issue: that the IMT Diluent volume remaining (%
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BYTE Aligner System BYTE All-Day Aligner System BYTE
The Issue: Virtual-only clinical workflow utilized for dental aligners and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENSE Breast Coil 3.0T 7ch
The Issue: safety issue where a patient may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: dS Breast 16ch 1.5T
The Issue: safety issue where a patient may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mammotrak Diagnostic Coil 1.5T
The Issue: safety issue where a patient may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: dS Breast 7ch 3.0T
The Issue: safety issue where a patient may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST SENSE Breast Dx Coil
The Issue: safety issue where a patient may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENSE Breast Coil
The Issue: safety issue where a patient may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: dS Breast 7ch 1.5T
The Issue: safety issue where a patient may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: dS Breast 16ch 3.0T
The Issue: safety issue where a patient may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST SENSE Breast Coil
The Issue: safety issue where a patient may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mammotrak Interventional Coil 1.5T
The Issue: safety issue where a patient may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mammotrak Diagnostic Coil 3.0T
The Issue: safety issue where a patient may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.