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 28781–28800 of 38,428 recalls
Recalled Item: Philips Healthcare PIIC Classic Upgrade
The Issue: Reconstructed ECG leads viewed or printed at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare IntelliVue Info Center iX
The Issue: Reconstructed ECG leads viewed or printed at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare IntelliVue Info Center iX
The Issue: Reconstructed ECG leads viewed or printed at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA)
The Issue: The firm was notified by some of their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reuseable rotary blade/abrader
The Issue: Weak weld in the reusable rotary blade/abrader (burr)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reuseable rotary blade/abrader
The Issue: Weak weld in the reusable rotary blade/abrader (burr)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reuseable rotary blade/abrader
The Issue: Weak weld in the reusable rotary blade/abrader (burr)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wilson Penile Implantation System Retractor Frame
The Issue: The firm was notified by some of their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS
The Issue: The firm was notified by some of their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RenovoCath RC 120
The Issue: Incorrect version of Instructions for Use were shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter
The Issue: for separation of the proximal handle from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for
The Issue: There is potential for small holes, the size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hook Blade
The Issue: The sterile blade will not fit into the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Oncology Information System. Used to manage workflows for treatment
The Issue: First Databank (FDB) is a third party product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona EM Distal Rod
The Issue: Complaints that the ratchet teeth of the tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona EM Proximal Tube
The Issue: Complaints that the ratchet teeth of the tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ZYTO Tower is the input device to program the
The Issue: ZYTO Technologies Inc. Announces a Voluntary Recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ZYTO Select and ZYTO Elite software programs are used
The Issue: ZYTO Technologies Inc. Announces a Voluntary Recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)
The Issue: improper bonding between the tube and luer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 30 deg
The Issue: This correction to the da Vinci Xi I&A
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.