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 8741–8760 of 38,428 recalls
Recalled Item: DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on...
The Issue: A component of a sub-assembly used in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clariti 1-day toric soft contact lenses
The Issue: The lenses manufactured in the affected lot were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis Anesthesia ES System (PAS ES)
The Issue: Automated dispensing cabinet drawer firmware may have inadvertently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brainlab ExacTrac Dynamic software
The Issue: Deep Inspiration Breath Hold (DIBH) functionality may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amicus Exchange Kit Therapeutics. Component of Amicus Separator...
The Issue: for centrifuge packs to develop a stress
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator
The Issue: for centrifuge packs to develop a stress
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FreeStyle Libre Reader
The Issue: Lithium-ion batteries in glucose monitoring system readers may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Global Total LP single step medium
The Issue: It has come to CooperSurgical's attention that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FreeStyle Libre Reader
The Issue: Lithium-ion batteries in glucose monitoring system readers may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FreeStyle Libre Reader
The Issue: Lithium-ion batteries in glucose monitoring system readers may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BEQ-HLS 5050 USA
The Issue: Firm has initiated a removal of the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips DreamStation Auto BiPAP and CPAP
The Issue: A limited number of remediated Philips DreamStation units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Xi Surgical System Model IS4000 da Vinci X
The Issue: Due to Universal Surgical Manipulator (USM) instrument carriage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed 7.0
The Issue: Due to potential leaks associate with the Oral/Nasal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensus Healthcare Inc
The Issue: When the user pauses the beam delivery, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MultiLab Series II ROODRA non-invasive vascular diagnostic device
The Issue: The current luer fittings and adaptors allow for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device
The Issue: The current luer fittings and adaptors allow for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MultiLab Series II REVO non-invasive vascular diagnostic device
The Issue: The current luer fittings and adaptors allow for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device
The Issue: The current luer fittings and adaptors allow for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FreeStyle Libre 3 App
The Issue: If using affected glucose monitoring app on Android
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.