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 13361–13380 of 38,428 recalls
Recalled Item: INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEEDLEMASTER 3MMx 26G LOWER
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INJECTOR FORCEMAX LOWER 25G 6MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PBD-203-0710 BILIARY STENT
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SD-240U-25 ELECTROSURGICAL SNARE
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-204 GUIDE SHEATH KIT 2.6MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B5-2Q BALLOON CATHETER
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-202 GUIDE SHEATH Kit 2.0MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B7-2Q BALLOON CATHETER 13MM DIA 3.2
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KD-650L ELECTROSURGICAL SNARE
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PBD-203-0704 BILIARY STENT
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEEDLEMASTER 5MMx 25G LOWER
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INJECTOR FORCEMAX UP 2MM CH 23G 3MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INJECTOR FORCEMAX LOWER 23G 6MM 5/BX
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INJECTOR FORCEMAX LOWER 23G 4MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.