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 5561–5580 of 38,428 recalls
Recalled Item: Hillrom Welch Allyn Spot Vision Screener VS100
The Issue: Baxter received reports of an issue related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RKN130002
The Issue: Due to firmware issues with the prosthetic knee,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RKNXC0005
The Issue: Due to firmware issues with the prosthetic knee,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RKNXC0003
The Issue: Due to firmware issues with the prosthetic knee,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RKN130003
The Issue: Due to firmware issues with the prosthetic knee,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors
The Issue: Software anomaly resulted in failure to detect a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5000 Compact Series Ultrasound Systems
The Issue: Ultrasound system with: 1) transesophageal echocardiography transducer (TEE)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINER
The Issue: A slight dimensional variation which has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINER
The Issue: A slight dimensional variation which has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP
The Issue: A slight dimensional variation which has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1
The Issue: A slight dimensional variation which has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure kits labeled as follows: a) CYSTO
The Issue: A slight dimensional variation which has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure kits labeled as follows: a) BASIC NASAL
The Issue: A slight dimensional variation which has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1
The Issue: A slight dimensional variation which has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure kits labeled as follows: a) AAA CDS
The Issue: A slight dimensional variation which has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure kits labeled as follows: a) TURNOVER KIT
The Issue: A slight dimensional variation which has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1
The Issue: A slight dimensional variation which has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure kits labeled as follows: a) KIT CANISTER
The Issue: A slight dimensional variation which has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical procedure kits labeled as follows: DENTAL
The Issue: A slight dimensional variation which has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1500ML SOFT LINER
The Issue: A slight dimensional variation which has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.