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 21181–21200 of 38,428 recalls
Recalled Item: MEDLINE Sterile* Needle Counter
The Issue: The product packaging seal has the potential to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE O.R. Necessities(R) STERILE R
The Issue: The product packaging seal has the potential to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE O.R. Necessities(TM) Sterile* Needle Counter
The Issue: The product packaging seal has the potential to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE O.R. Necessities(TM) Sterile* Needle Counter
The Issue: The product packaging seal has the potential to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE Sterile* Needle Counter
The Issue: The product packaging seal has the potential to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE Sterile* Needle Counter
The Issue: The product packaging seal has the potential to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex 7.20 US
The Issue: Baxter Healthcare will be installing new firmware on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex System
The Issue: Baxter Healthcare will be installing new firmware on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex 7.XX US
The Issue: Baxter Healthcare will be installing new firmware on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex 7.XX ROW
The Issue: Baxter Healthcare will be installing new firmware on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex 5.10 US
The Issue: Baxter Healthcare will be installing new firmware on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3
The Issue: The fuel gauge, the component that reads and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Xi EndoWrist Stapler 45 Reload Green
The Issue: Intuitive Surgical, Inc. (ISI) has recently become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Xi EndoWrist Stapler 45 Reload Blue
The Issue: Intuitive Surgical, Inc. (ISI) has recently become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil
The Issue: Non-sterile product was packaged inside a case that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A warming pad
The Issue: Malfunction warming pad
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris
The Issue: Complaints where users were unable to prime the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINX Management System
The Issue: out of specification condition which may allow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Go.Up
The Issue: There is a potential for a software issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.Now
The Issue: There is a potential for a software issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.