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 12781–12800 of 38,428 recalls
Recalled Item: 10G DIRECT SINGLE - ACCESS
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InterV 11G Kyphoplasty Kit
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty Direct Access Bevel Tip Trocar
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11G DIRECT WORKING CANNULA DIAMOND TIP MINI
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10 GAUGE CEMENT DELIVERY CANNULA
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty Directional Cement Cannula Long
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty Direct Bipedicular Bone Access Kit with Drill
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10G DIRECT SINGLE - ACCESS
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty Biopsy Device
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Infusion Pump Module
The Issue: Bezel repair part, not by the original manufacturer,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty 10G
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10 GAUGE CEMENT DELIVERY CANNULA
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty Unipedicular Cement Delivery Cannula Kit
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERTEBREX SINGLE BALLOON KIT
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OsteoFlex BONE CEMENT
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty 10G
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.