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 22701–22720 of 38,428 recalls
Recalled Item: Rosen Curved Wire Guide
The Issue: Label does not state that the product is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Newton Wire Guide
The Issue: Label does not state that the product is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Light Handle Cover
The Issue: Sterile packaging of the disposable light handle cover
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate
The Issue: This voluntary recall is being conducted due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage:
The Issue: Gamma sterilization validation testing indicates the sterilization dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TunneLoc Tibial Fixation Device Product Usage: To provide fixation of
The Issue: Gamma sterilization validation testing indicates the sterilization dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestation 620 A2
The Issue: incomplete seal between the CO2 absorber and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestation 620 A1
The Issue: incomplete seal between the CO2 absorber and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK2 GP-ID
The Issue: Customers have reported, and an internal investigation has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the
The Issue: The device may contain a manufacturing condition affecting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit
The Issue: The device may contain a manufacturing condition affecting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Dental Instrument Kit System
The Issue: The device may contain a manufacturing condition affecting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Dental Instrument Kit System
The Issue: The device may contain a manufacturing condition affecting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arkon Anesthesia Delivery System
The Issue: Arkon Anesthesia Workstation, with software version 2.61, experienced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Crimson Trace Corporation laser sights. The Finished Products are laser
The Issue: A previously "in specification" Finished Product with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYSTEM 26. Part Numbers: OS900035-NS
The Issue: Following the identification of corrosion residue found inside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic CareLink iPro Therapy Management Software
The Issue: Due to a time conversion error, data uploaded
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImplantDirect Legacy(TM) 3 Implant
The Issue: One reported complaint and discovered that the outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER
The Issue: Products labeled as sterile were distributed prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER
The Issue: Products labeled as sterile were distributed prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.