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 16761–16780 of 38,428 recalls
Recalled Item: 2.4mm x 2.5 Fluted Pin Pouch
The Issue: for the 2.4mm x 2.5 Fluted Pin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCFE (slipped capital femoral epiphysis) Knobs for Driver
The Issue: There is a potential for the screws to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aesculap Sterile disposable fleece drape
The Issue: Packaging seal integrity not validated resulting in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F
The Issue: Firm has identified that the product may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. X-Port isp M.R.I Implantable Port
The Issue: Firm has identified that the product may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl
The Issue: Firm has identified that the product may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen
The Issue: Firm has identified that the product may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen
The Issue: Firm has identified that the product may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. Power Port isp M.R.I. Implantable Port with Attachable 9.6
The Issue: Firm has identified that the product may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen...
The Issue: Firm has identified that the product may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs
The Issue: Firm has identified that the product may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended
The Issue: Firm has identified that the product may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. Groshong 9.5 Dual-Lumen CV Catheter
The Issue: Firm has identified that the product may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Low Profile Screw
The Issue: Screws provided in the device package are 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoTool SubQ (Versions 1.7.1
The Issue: Product was distributed prior to approval or clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accutorr 3 Vital Signs Monitor with NIBP valve assembly board
The Issue: NIBP valve assembly board subject to this recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rosebud Vital Signs Monitor with NIBP valve assembly board
The Issue: NIBP valve assembly board subject to this recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rosie4 Vital Signs Monitor with NIBP valve assembly board
The Issue: NIBP valve assembly board subject to this recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accutorr 7 Vital Signs Monitor with NIBP valve assembly board
The Issue: NIBP valve assembly board subject to this recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Glucose Monitoring System
The Issue: power issues with the Accu-Chek¿ Guide Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.