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 23221–23240 of 38,428 recalls
Recalled Item: QIAamp DSP Virus Kit Cat. No. 60704
The Issue: Certain lots of the QIAamp DSP Virus Kit,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPIFE ImmunoFix-6 Kit
The Issue: The plates do not have wells punched for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accolade and Restoration hip product
The Issue: Inner and outer sterile barriers not fully sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accolade and Restoration hip product
The Issue: Inner and outer sterile barriers not fully sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right
The Issue: The locking mechanism and protective cap were missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #:
The Issue: It was identified that the Mistral-Air Premium blankets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Certitude Delivery System and any associated Multipacks Models - 9600CT20A
The Issue: A component in the Certitude Loader may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implant Direct Swish Duo-Grip Healing Collar
The Issue: The Swish Duo-Grip Healing Collar part number 9048-13H
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FUJINON ED-530XT. This device is intended for the visualization of
The Issue: An update to the design and labeling was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K
The Issue: Reagent carryover from Sekisui ACTH when utilized on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENICON EZEE Retrieval
The Issue: Plastic handle is breaking off of shaft inhibiting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percuvance Maryland Dissector Tool Tip The Percutaneous Surgical System with
The Issue: For some of the recalled products, the security
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with
The Issue: For some of the recalled products, the security
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percuvance 29cm Shaft The Percutaneous Surgical System with 5mm attachments
The Issue: For some of the recalled products, the security
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with
The Issue: For some of the recalled products, the security
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percuvance Scissors Tool Tip The Percutaneous Surgical System with 5mm
The Issue: For some of the recalled products, the security
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with
The Issue: For some of the recalled products, the security
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Assay(R) Multi-Analyte Calibrator
The Issue: The AlAT calibrator values in the package insert
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas 6000 Modular Series system
The Issue: A warning is being added to the cobas¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas 8000 Modular Analyzer Series
The Issue: A warning is being added to the cobas¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.