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 11241–11260 of 38,428 recalls
Recalled Item: JAGTOME RX 49-30-260-035 Material Number: M00573020
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYDRATOME RX 44-30MM/260CM Material Number: M00583050
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Destino Twist 14F (also branded as Guidestar 14F)
The Issue: There is potential for separation between the threaded
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIM TRIVANTAGE EMG Endotracheal Tube
The Issue: There is potential for multiple issues due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors -
The Issue: The External Retention Bolster contained in the kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Chuck-The Universal Chuck is an Instrument Handle provided as
The Issue: Top cap may loosen and detach if the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
The Issue: The External Retention Bolster contained in the kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImmunoPass
The Issue: COVID test kits were offered for sale and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CovClear COVID-19 Rapid Antigen Test
The Issue: COVID test kits were offered for sale and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo
The Issue: Philips has identified a specific lot of non-conforming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8mm FlexDex Needle Driver
The Issue: The firm is reinforcing the IFU instructions: "Do
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo Repair Kit
The Issue: Philips has identified a specific lot of non-conforming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SonarMed AirWave Monitor Kit (Monitor
The Issue: Prior to use on a patient, the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-Peptide ELISA : IVD measurement of C-Peptide in serum
The Issue: ODs of the standards too low(< 0.6 ODmax)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endurant
The Issue: Stent Graft Systems built with specific batches of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 32MM -4 V40 TAPER VIT HEAD
The Issue: There is a potential for the outer Tyvek
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL
The Issue: There is a potential for the outer Tyvek
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bellavista 1000 ventilator
The Issue: cessation in ventilation can occur under specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: API ID 32 C Strips
The Issue: Risk of misidentification or delayed results with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flat Panel Detector
The Issue: Abnormal images such as horizontal stripes may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.