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 12081–12100 of 38,428 recalls
Recalled Item: Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in
The Issue: Product does not meet the Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in
The Issue: Product does not meet the Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advance Dx 100 Blood Collection Card Quantity 25
The Issue: Due to high glucose test results when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoolSculpting Elite System The CoolSculpting System SW release 2.0
The Issue: An incorrect error messaging system that could potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Torque Limiting Adaptor
The Issue: There is a risk of breakage of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Hero Model 100 (H-100) is a system consisting of
The Issue: Due to dispenser prompting for a missed dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Potassium Hydroxide 10% (KOH 10%)
The Issue: A lot of KOH 10% was made with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee
The Issue: Package labeled as 16mm x 80mm contained a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triathlon Prim CEM FXD BPLT 7
The Issue: The internal profile of the Triathlon Prim (Baseplate)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Arthroscopy Kit
The Issue: The kits may contain an expired component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCESS SARS-CoV-2 ANTIGEN QC
The Issue: SARS-CoV-2 Antigen Assay test may generate false positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION
The Issue: SARS-CoV-2 Antigen Assay test may generate false positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Knee Arthroscopy Kit
The Issue: The kits may contain an expired component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCESS SARS-CoV-2 Antigen
The Issue: SARS-CoV-2 Antigen Assay test may generate false positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Total Knee
The Issue: The kits may contain an expired component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Shoulder CDS convenience kits
The Issue: The kits may contain an expired component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access SARS-CoV-2 Antigen Calibrators
The Issue: SARS-CoV-2 Antigen Assay test may generate false positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlideScope Go Monitors
The Issue: Handheld video monitor failed to meet the labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RIGHT CORONAL BENDER
The Issue: Customized coronal rod benders may deform the implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEFT CORONAL BENDER
The Issue: Customized coronal rod benders may deform the implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.