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 35281–35300 of 38,428 recalls
Recalled Item: LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula
The Issue: Product contains particulates (fibers)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product
The Issue: Product contains particulates (fibers)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch
The Issue: Product contains particulates (fibers)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Indus Invue Screw Caddy
The Issue: Difficulty removing screws from the Invue caddies
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MHI-TM2000 Linear Accelerator System
The Issue: Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Picis ED Pulsecheck - EMR Software Application - 2125
The Issue: Notes associated with prescription are not printed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Myoscience brand iovera Smart Tip
The Issue: The outer box label of the product was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose...
The Issue: Research Use Only (RUO) parameters were included in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TDHistology/Cytology Classification name: Calculator/data processing module...
The Issue: A recall was initiated by Technidata because use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRX Revolution
The Issue: Carestream Health Inc. is conducting a recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE
The Issue: Single packaging configuration used for the VERSA-FX-II Femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Free Lock Femoral Hip Fixation System Compression Lag Screw .
The Issue: Single packaging configuration used for the VERSA-FX-II Femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Free Lock Femoral Hip Fixation System Compression Tube/Plate
The Issue: Single packaging configuration used for the VERSA-FX-II Femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE
The Issue: Single packaging configuration used for the VERSA-FX-II Femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well
The Issue: Siemens is conducting a field correction for Dimension
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW
The Issue: Single packaging configuration used for the VERSA-FX-II Femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx Monitor/Defibrillator
The Issue: The MRx may deliver a non-synchronized cardioversion shock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Suction Wand
The Issue: Edwards is recalling certain lots of Rigid Suction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.