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 27941–27960 of 38,428 recalls
Recalled Item: MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
The Issue: Complaints that the cannula bent/broke during surgery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
The Issue: MicroAire has initiated a recall on product PAL-R4011XL
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TF Adaptive Gutta Percha Point Size SM3 50pk
The Issue: Ormco Corporation is recalling the TF Adaptive Gutta
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge PACS software. The firm name on the label is Merge Healthcare
The Issue: When measuring a lesion on an unmagnified mammography
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allegra X-5 rotor yoke
The Issue: A defective rotor yoke on Allegra X-5 allows
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT SP Computed Tomography X-ray Systems
The Issue: The firm was notified of a software error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity CT Computed Tomography X-ray Systems
The Issue: The firm was notified of a software error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64:Computed Tomography X-ray Systems
The Issue: The firm was notified of a software error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 128 Computed Tomography X-ray Systems
The Issue: The firm was notified of a software error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core Computed Tomography X-ray Systems
The Issue: The firm was notified of a software error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT Computed Tomography X-ray Systems
The Issue: The firm was notified of a software error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard XP Knee System Porous Femoral Component various sizes and
The Issue: The anterior/posterior (AP) dimension may be oversized by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transport Stretcher
The Issue: The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prime Series Stretchers (Fifth Wheel
The Issue: The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano R100 Sterile Equipment Cover
The Issue: Volcano Corporation has identified that certain lot numbers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano SpinVision Sterile Equip cover II
The Issue: Volcano Corporation has identified that certain lot numbers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide
The Issue: Bard Peripheral Vascular, Inc. is recalling Bard TruGuide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MitraClip Clip Delivery System
The Issue: Abbott Vascular has recently received reports of cases
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog
The Issue: ADVIA Centaur Systems Calibrator E Lot 42 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog
The Issue: ADVIA Centaur Systems Calibrator E Lot 42 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.