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 19381–19400 of 38,428 recalls
Recalled Item: Avenir¿ Muller Stem Standard
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Protexis Neoprene Surgical Glove
The Issue: Labeling issue in that the breakthrough (i.e., permeation)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Protexis Neoprene Surgical Glove
The Issue: Labeling issue in that the breakthrough (i.e., permeation)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Protexis Neoprene Surgical Glove
The Issue: Labeling issue in that the breakthrough (i.e., permeation)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Protexis Neoprene Surgical Glove
The Issue: Labeling issue in that the breakthrough (i.e., permeation)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm)
The Issue: This voluntary recall is being conducted due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clinical Chemistry
The Issue: for chemical analyzer to report abnormal results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Porcine Anorganic Bone Mineral 4.0cc
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implant Direct
The Issue: packaging error; An internal QA inspection revealed that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Procedure Kit
The Issue: Labeling error; It was identified that a Procedure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Procedure Kit
The Issue: Labeling error; It was identified that a Procedure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Zee and Zeego
The Issue: This recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci SP Instrument Arm Drape. QTY 1 Pouch
The Issue: The instrument drape may tear while draping the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
The Issue: A stray strand of stainless-steel cable may protrude
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO
The Issue: There is a potential for blood leakage at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO
The Issue: There is a potential for blood leakage at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEOCONNECT
The Issue: The sterile pouch label states the expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet 20mm Compress Device Short Anchor Plug With Drill Set
The Issue: metal burrs in the holes of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The da Vinci SP surgical system is made of three
The Issue: The firm became aware of a problem with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice
The Issue: Software defect: For Helical scan with ClearView function,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.