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 29161–29180 of 38,428 recalls
Recalled Item: Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit
The Issue: Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Antibacterial Hydro Personal Catheter
The Issue: Incorrect unit labeling. The case label and shelf
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Welch Allyn KleenSpec Corded Illumination System
The Issue: The firm became aware that the KleenSpec¿ 788
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Cardio software. Merge Cardio is a system intended to
The Issue: Reporting feature times out after inactivity for more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It
The Issue: Hummingbird Med Devices, Inc. is recalling ABG-HM-1 Hummi
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips X-Ray Systems
The Issue: Upon initiating Fluoroscopy the user may encounter a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The "Pacifier Activated Lullaby" (PAL) System composed of three major
The Issue: PAL unit has undergone significant technological changes since
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triton Infusion Pump (model 300000) and Triton fp Infusion Pump
The Issue: The device might fail to detect air in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Burn Relief¿
The Issue: For lack of evidence to validate effectiveness of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista System (MG)
The Issue: Erroneous low results on a small number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shimadzu C-arm Table
The Issue: The C-arm may interfere with the table top
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD CD3 (SK7) FITC
The Issue: Two lots of CD3 (SK7) FITC label contains
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof
The Issue: Continued increase in reports of post-operative inflammation in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics
The Issue: Stryker is recalling various lots of the Trithion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses
The Issue: Tekia is recalling the Single Piece Hydrophillic Acrylic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MaxAn 4.0mm and 4.5mm fixed screws
The Issue: The packaging of 4.5 mm diameter MaxAn screws
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Achieve Cables
The Issue: 64 units of Achieve Electrical Cables were shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal...
The Issue: Incorrect external and internal packaging labels. Exactech has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Centricity Universal Viewer Version is a device that displays
The Issue: Inaccurate distance measurements with magnified projection X-ray images
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Centricity PACS-IW with Universal Viewer is a device that
The Issue: Inaccurate distance measurements with magnified projection X-ray images
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.