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 16421–16440 of 38,428 recalls
Recalled Item: Ascension¿ Silicone PIP-Silicone PIP Sz 1
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Healix Knotless ADV BR 4.75 Suture Anchor
The Issue: Specific product codes and lots of the Mitek
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Healix Knotless ADV BR 5.5 Suture Anchor
The Issue: Specific product codes and lots of the Mitek
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the
The Issue: The indicator may show available charge when the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioPlex 2200 ANA Screen Control Set
The Issue: A new lot of ANA screen control and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube - Product
The Issue: The tracheal and brochial swivel connectors are incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Pediatric Circuit 72"
The Issue: The 10mm inner green inspiratory tubing is disconnected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biopsy Needle FPU Kit
The Issue: The firm has become aware that due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oral-B
The Issue: Product shelf life may be shorter than that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biopsy Needle FPU Kit
The Issue: The firm has become aware that due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Passive Biopsy Needle Kit
The Issue: The firm has become aware that due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XEN Gel Stent
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive
The Issue: Product has the potential to be contaminated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroDot brand: Wave Prep Single use cups
The Issue: Product has the potential to be contaminated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062
The Issue: The frequency of calibration for the Genius Tympanic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genius 2 Tympanic Thermometer Private Label Item Code: 3069
The Issue: The frequency of calibration for the Genius Tympanic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000
The Issue: The frequency of calibration for the Genius Tympanic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
The Issue: The frequency of calibration for the Genius Tympanic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063
The Issue: The frequency of calibration for the Genius Tympanic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iChemVELOCITY
The Issue: Customers have reported incidents where two sets of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.