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 13341–13360 of 38,428 recalls
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: INJECTOR FORCEMAX SIF 270CM 23G 4MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KD-620LR 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: MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SD-210U-15 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: SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m
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 5MM
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-15 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: K-203 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: PBD-203-0703 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: INJECTOR FORCEMAX UP 2.8MMCH 23G 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 5MMx 25G UPPER
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-201 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: INJECTOR FORCEMAX LOWER 25G 5MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B5-2C BALLOON CATHETER 11MM DIA 2.0
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-201 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: INJECTOR FORCEMAX LOWER 25G 5MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KD-655L 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-401D-1521 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: PBD-203-0707 BILIARY STENT
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.