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 5181–5200 of 38,428 recalls
Recalled Item: MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE
The Issue: It has been identified that testing documentation does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number:
The Issue: Alcon has detected an increase in complaint reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A
The Issue: Alcon has detected an increase in complaint reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number:
The Issue: Alcon has detected an increase in complaint reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Captus 4000e Thyroid Uptake System. Intended to be used to
The Issue: Complaints of unexpected detachment of the collimator have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Captus 4000e Thyroid Uptake System with Well. Intended to be
The Issue: Complaints of unexpected detachment of the collimator have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Captus 4000e Thyroid Uptake System with Well and 2 inch
The Issue: Complaints of unexpected detachment of the collimator have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541
The Issue: Alcon has detected an increase in complaint reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR)
The Issue: Philips Ingenia Evolution systems with software R5.7.1 may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance
The Issue: Philips Ingenia Evolution systems with software R5.7.1 may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient Information Center iX and Patient Information Center iX Expand
The Issue: Event Catalog information does not save when copied
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter Dxl 9000 Access Immunoassay Analyzer
The Issue: When the DxI 9000 Access Immunoassay Analyzer with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mi1250 SYNCHRONY 2
The Issue: A small number of devices may have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 9000 Access Immunoassay Analyzer
The Issue: Beckman Coulter is recalling their DxI 9000 Access
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTETRAK Inset Patella
The Issue: Exactech is recalling all affected UHMWPE (ultra-high molecular
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTETRAK Three Peg Patella
The Issue: Exactech is recalling all affected UHMWPE (ultra-high molecular
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTETRAK
The Issue: Exactech is recalling all affected UHMWPE (ultra-high molecular
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTETRAK One Peg Patella
The Issue: Exactech is recalling all affected UHMWPE (ultra-high molecular
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Synchro2 Guidewires are a steerable guidewire family with a
The Issue: Stryker Neurovascular has observed an increased frequency of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back
The Issue: Due to infusion set tubing drip chamber becoming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.