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 17861–17880 of 38,428 recalls
Recalled Item: SOLOPATH Re-Collapsible Access System
The Issue: There is a potential for dislodgement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ThermaCare HEATWRAPS
The Issue: There is the potential that a HeatWrap could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-Reactive Protein Kit for use on the SPAplus
The Issue: A reagent in C reactive protein kits is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lidar System for Erosion Flume Application Class 1 Laser Product
The Issue: Failure to comply event due to incorrect labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product
The Issue: risk of brush detachment during cleaning. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
The Issue: The bearings of the saw attachments were ungreased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application
The Issue: The bearings of the saw attachments were ungreased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thirty-five (35) cm 8 Contact Extension Kit
The Issue: The firm is initiating a voluntary removal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LinearTM 3-4 50 cm 8 Contact Lead Kit
The Issue: The firm is initiating a voluntary removal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fifty-five (55) cm 8 Contact Extension Kit
The Issue: The firm is initiating a voluntary removal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fifty-five (55) cm 8 Contact Extension Kit
The Issue: The firm is initiating a voluntary removal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Precision TM M8 Adapter
The Issue: The firm is initiating a voluntary removal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The LinearTM 3-4 70 cm 8 Contact Lead Kit
The Issue: The firm is initiating a voluntary removal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ArtisanTM 70 cm 2 x 8 Surgical Lead Kit
The Issue: The firm is initiating a voluntary removal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PEDIATRIC PICC INSERTION TRAY CVI4450A
The Issue: Firm distributes kits which include the BD MaxZeroNeedleess
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OR VANTEX 7FR 3L 16CM CVC ECVC6665
The Issue: Firm distributes kits which include the BD MaxZeroNeedleess
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC Line Accessory Kit CVI4285
The Issue: Firm distributes kits which include the BD MaxZeroNeedleess
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535
The Issue: Firm distributes kits which include the BD MaxZeroNeedleess
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neonatal Cap Change Kit DT20315
The Issue: Firm distributes kits which include the BD MaxZeroNeedleess
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CVC BUNDLE
The Issue: Firm distributes kits which include the BD MaxZeroNeedleess
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.