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 8881–8900 of 38,428 recalls
Recalled Item: Atellica IM Folate 700 test kit- For in vitro diagnostic
The Issue: Negative bias occurred when whole blood calibration (Atellica
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic
The Issue: Negative bias occurred when whole blood calibration (Atellica
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Folate 500 test kit- For in vitro diagnostic
The Issue: Negative bias occurred when whole blood calibration (Atellica
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: abm Respiratory Care Standart Breating Circuit with Face Mask -
The Issue: Incorrect expiration date on product label. The manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WishBone Medical Smart Correction Dual Joint Express Struts
The Issue: Firm identified that user may be unable to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter
The Issue: Due to the adhesive provided within the catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR
The Issue: Gauge malfunction: Digital gauge displays an incorrect tank
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops
The Issue: Face masks were placed into the incorrect dispenser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Vanguard Knee System PS Open Box Femoral
The Issue: Components Incorrectly labeled as either smaller or larger
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Vanguard Knee System PS Open Box Femoral
The Issue: Components Incorrectly labeled as either smaller or larger
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Medline Sterile Hand Pack
The Issue: The convenience trays had improper placement of some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Sterile Oncology Port Access Tray
The Issue: The convenience trays had improper placement of some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Medline Sterile Maximum Barrier Pack-LF
The Issue: The convenience trays had improper placement of some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic)
The Issue: Lenses may be of the incorrect power. A
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Incisive CT
The Issue: Multiple software issues which have the potential to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8
The Issue: Fixation screw was inserted through the wrong side
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8
The Issue: Fixation screw was inserted through the wrong side
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Precision Delivery Set with Filter
The Issue: Delivery Sets may have tubing that could become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CENTURION MEDICAL PRODUCTS
The Issue: The kit contained an expired component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR VVC KNEE TIBIAL INSERT
The Issue: Tibial insert implant large boxes were labeled small
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.