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 12841–12860 of 38,428 recalls
Recalled Item: BPB medica CEMIX
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES)
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11G DIRECT SINGLE - ACCESS
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CEMENT MIXING SYSTEM
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10G DIRECT SINGLE - ACCESS
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL)
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10G DIRECT WORKING CANNULA BEVEL TIP 15CM
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10 GAUGE DRILL
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8G DIRECT WORKING CANNULA BEVEL TIP
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8G DIRECT WORKING CANNULA BEVEL TIP
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EASYNJECT
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10G COAXIAL CANNULA WITH TUOHY CONNECTION
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10 GAUGE CEMENT DELIVERY CANNULA
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CEMIX - CEMENT MIXING SYSTEM
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11G DIRECT WORKING CANNULA DIAMOND TIP MINI
The Issue: Products labeled as sterile were distributed, but may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue IABP - Product Usage: used to inflate and
The Issue: There are cybersecurity vulnerabilities in a widely used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.