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 22961–22980 of 38,428 recalls
Recalled Item: Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter...
The Issue: Unpaired lots of AU lyophilized chemistry calibrator level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis
The Issue: Within a specific number of Artis zee biplane
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient
The Issue: In certain cases, the lock and key supplied
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IVEA Product Part Number 16100 Model 500A
The Issue: The dowel pins (P/N 16082) that fit in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.plaza systems with SW VB20A
The Issue: When a prior study is being replaced in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Multi Measurement Server
The Issue: Distorted ST-Segment when using 12-Lead ECG Monitoring with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray
The Issue: It was discovered a low-level radiation leak that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser
The Issue: The high control for the kit is recovering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziptight Ankle Syndesmosis Fixation Device
The Issue: Ziptight Ankle Syndesmosis Fixation was packaged without the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis oneFloor-mounted system for uncompromised imaging
The Issue: The possibility exists for the monitor display of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion
The Issue: for the syringe barrel clamp mechanism to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion
The Issue: for the syringe barrel clamp mechanism to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer
The Issue: Beckman Coulter has identified that an incorrect setting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TCC-EZ
The Issue: A quarantined lot of the devices was released
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A20975A "Working insert
The Issue: Olympus has received complaints about fragments of adhesive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.plaza Picture Archiving and Communication System (PACS) with software...
The Issue: Software update to correct several issues that include
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive...
The Issue: Intermittent communication between the host system and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 3 M12
The Issue: When using the downscale option with the Allura
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coated VICRYL RAPIDETM (Polyglactin 910) Suture
The Issue: On August 17, 2017, Ethicon had decided to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device
The Issue: The CO/CO2 sensor cable harness may have lower
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.