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 8341–8360 of 38,428 recalls
Recalled Item: Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
The Issue: Metal mounting box on the rotating scanner on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
The Issue: Metal mounting box on the rotating scanner on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventralight ST w Echo PS 4.5" Circle A low profile
The Issue: Balloon may not inflate as intended. If the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventralight ST w EchoPS 4"x6" Ellipse- A low profile
The Issue: Balloon may not inflate as intended. If the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventralight ST 4.5" Circle with Echo PS- A low profile
The Issue: Balloon may not inflate as intended. If the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
The Issue: Balloon may not inflate as intended. If the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample
The Issue: Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK SymphoKnee System L-Shaped Femoral Augment
The Issue: Contains the incorrect implant in the packaging. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xpert Xpress Strep A
The Issue: pipettes packaged in Strep A test may fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xpert Xpress Strep A
The Issue: pipettes packaged in Strep A test may fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVNS ambIT System - PIB/PCA W 2.5in Cath
The Issue: Some of the ambIT kits were potentially distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity i Anti-TPO Reagent Kit
The Issue: Due to a manufacturing fill volume error, Alinity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMMT ambIT Kit Basic Filter Luer Cass
The Issue: Some of the ambIT kits were potentially distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ambIT Cassette Filter Male Luer
The Issue: Some of the ambIT kits were potentially distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMMT ambIT Reusable Program - Luer Cass
The Issue: Some of the ambIT kits were potentially distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVNS ambIT System - PIB/PCA W 5in Cath
The Issue: Some of the ambIT kits were potentially distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aligned Medical Solutions Hand Pack
The Issue: Light handle covers may separate from the light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aligned Medical Solutions Minor Hand Pack
The Issue: Light handle covers may separate from the light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aligned Medical Solutions Spine Pack
The Issue: Light handle covers may separate from the light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aspira Pleural Drainage Catheter Insertion Tray 15.5F
The Issue: There is a potential that valve assemblies will
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.