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 11921–11940 of 38,428 recalls
Recalled Item: Catalog A902416
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMSORB PLUS PREFILLED G-CAN 1.0L
The Issue: Some devices may be associated with high and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vysis CLL FISH Probe Kit with the following components: Vysis
The Issue: for Vysis CLL FISH Probe Kits not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System
The Issue: Customers have reported an increased number of false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical portex Tracheal Intubation Stylet
The Issue: The incorrect device is contained in the package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 0.9% Sodium Chloride Flush Syringe
The Issue: for the plunger to draw back after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 0.9% Sodium Chloride Flush Syringe
The Issue: for the plunger to draw back after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 0.9% Sodium Chloride Flush Syringe
The Issue: for the plunger to draw back after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AquaBplus Water Purification System
The Issue: AquaBplus HF module on the AquaBplus 2000 osmosis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene EP Amplification Reagent Kit Test
The Issue: There is potential for false positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8
The Issue: Packaging seal defect may allow a breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: uEXPLORER PET/CT System - Product Usage: intended to be operated
The Issue: The EXAM acquisition workflow could occasionally freeze after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow sensors that may be installed in the following GEHC
The Issue: The flow sensors built prior to June 2021
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: uMI 550 System - Product Usage: intended to be operated
The Issue: The EXAM acquisition workflow could occasionally freeze after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow sensors kept as stand-alone user replaceable spare parts for
The Issue: The flow sensors built prior to June 2021
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.