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 7641–7660 of 38,428 recalls
Recalled Item: ACROBAT SUV Vacuum Off-Pump System
The Issue: The Standard Blade may not securely latch onto
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCESSRAIL Platform (Standard Blade) Part Number SB-1000
The Issue: The Standard Blade may not securely latch onto
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACROBAT-i Vacuum Stabilizer System
The Issue: The Standard Blade may not securely latch onto
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACROBAT V Vacuum Off-Pump System
The Issue: The Standard Blade may not securely latch onto
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6
The Issue: Thread form issue of the locking holes in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISee Ortho-K Lens
The Issue: Manufactured lenses are not covered by existing FDA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fargo Ortho-K Lens
The Issue: Manufactured lenses are not covered by existing FDA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Digisonics OBView Versions 4.8.2 SP6 - 4.8.3
The Issue: Software issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UroLift Visual Obturator
The Issue: There is an improperly performed weld between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ellacor System with Micro-Coring Technology-Indicated for use by medical...
The Issue: failure of a bearing adhesive joint that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape
The Issue: Certain lots of the products have a Naphthalene
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equipment and table drapes and Surgical Room Turnover (SRT) Kits:
The Issue: Certain lots of the products have a Naphthalene
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINEAR 7.5Fr.IAB
The Issue: During IAB catheter insertion, the introducer dilator may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENSATION 7 Fr. IAB
The Issue: During IAB catheter insertion, the introducer dilator may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: YAMATO PLUS IAB
The Issue: During IAB catheter insertion, the introducer dilator may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENSATION PLUS 7.5Fr IAB
The Issue: During IAB catheter insertion, the introducer dilator may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRANS-RAY IAB
The Issue: During IAB catheter insertion, the introducer dilator may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGA 7.5Fr.IAB
The Issue: During IAB catheter insertion, the introducer dilator may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REINFORCED INTRODUCER SET
The Issue: During IAB catheter insertion, the introducer dilator may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGA 8Fr. IAB
The Issue: During IAB catheter insertion, the introducer dilator may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.