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 6441–6460 of 38,428 recalls
Recalled Item: Product Code 0848
The Issue: Affected product codes are now limited to use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Code 0847
The Issue: Affected product codes are now limited to use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Code 0846
The Issue: Affected product codes are now limited to use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Code 0845
The Issue: Affected product codes are now limited to use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terragene Bionova PCD (PCD222-C)
The Issue: Due to a discrepancy between the FDA-Cleared Indications
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental
The Issue: Due to a discrepancy between the FDA-Cleared Indications
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit
The Issue: A calibration error associated with the Flat Panel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator
The Issue: During internal review of Polaris battery assembly data
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MINC+ Benchtop Incubator
The Issue: The MINC+ device is susceptible to losing temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Incisive CT
The Issue: If the Patient Interface Monitor (PIM) Cable is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Neurovascular
The Issue: The microcatheter IFU contains an intended use that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Neurovascular
The Issue: The microcatheter IFU contains an intended use that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accure Laser System
The Issue: Laser system's spot tracking system may become misaligned
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Flo-Thru Intraluminal Shunt
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Floseal Hemostatic Matrix Fast Prep
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vascu-Guard Peripheral Vascular Patch (US)
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter FloSeal Hemostatic Matrix NL
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Flo-Rester
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERI-GUARD SUPPLE
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Coseal Premix
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.