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 13101–13120 of 38,428 recalls
Recalled Item: SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray
The Issue: Burkholderia cepacia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge...
The Issue: Customers are being notified of results from a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge...
The Issue: Customers are being notified of results from a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge...
The Issue: Customers are being notified of results from a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only).
The Issue: total iron-binding capacity (TIBC) results. The VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct
The Issue: Teleflex is voluntarily recalling the products referenced above
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA
The Issue: Discoloration and turbidity were present in the specified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream Dental CS 3600 Single Use Normal Tips
The Issue: The mirror may become detached and fall from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail
The Issue: Due to not having the full complement of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System
The Issue: Due to not having the full complement of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End
The Issue: Due to not having the full complement of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRECICE PLATE - Product Usage: intended for limb lengthening
The Issue: Due to complaints of adverse events potentially related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRECICE STRYDE - Product Usage: intended for limb lengthening
The Issue: Due to complaints of adverse events potentially related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Precice Bone Transport - Product Usage: intended for limb lengthening
The Issue: Due to complaints of adverse events potentially related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PLEUR-EVAC Thoracic Catheters (CATHETER
The Issue: Teleflex is recalling this product due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products
The Issue: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro...
The Issue: VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Valiant Navion Thoracic Stent Graft System. For endovascular repair of
The Issue: Due to the presence of type IIIb endoleaks,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and...
The Issue: The tube holder can separate from the barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.