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 38141–38160 of 38,428 recalls
Recalled Item: ******eMax 2 Plus Console***SN G 10307653002*** Product Usage: The
The Issue: The RPM of the Motor Handpiece may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ******eMax 2 Plus Console
The Issue: The RPM of the Motor Handpiece may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ******eMax 2 Plus Console
The Issue: The RPM of the Motor Handpiece may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids
The Issue: Update Instruction For Use for Preventative Maintenance (PM)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty
The Issue: On 06/08/2011, BioDerm, Inc. issued a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The
The Issue: On 06/08/2011, BioDerm, Inc. issued a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral
The Issue: On 06/08/2011, BioDerm, Inc. issued a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Varian High Energy Clinacs
The Issue: Under certain conditions, photon beams in High Energy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The product affected by this notice is sold under the
The Issue: This field notice concerns two behaviors of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A
The Issue: Beginning May 24, 2011 Stryker Neptune 2 (N2)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A
The Issue: Beginning May 24, 2011 Stryker Neptune 2 (N2)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ******Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
The Issue: Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ******Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
The Issue: Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare reported a potential safety issue due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DPM Central Station Mindray DS USA
The Issue: There is a software anomaly with the DPM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima MR450w
The Issue: An error on the SR Viewer Reporting Tool
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Catalog (part number 20-0020) utilized with the Electric and
The Issue: Anspach Effort, Inc. Palm Beach Gardens, FL initiated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cutting Bur Chart (part number 20-0019) utilized with the Electric
The Issue: Anspach Effort, Inc. Palm Beach Gardens, FL initiated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the
The Issue: Anspach Effort, Inc. Palm Beach Gardens, FL initiated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00...
The Issue: Braemar Inc., became aware of a battery related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.