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 19721–19740 of 38,428 recalls
Recalled Item: TiLite X-Short anti-tip tubes
The Issue: The anti-tip tubes potentially fail in certain situations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROCARE B20 Patient Monitor
The Issue: Patient monitors may restart due to network overload
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B20i Patient Monitor and B20i V2 Patient Monitor. The device
The Issue: Patient monitors may restart due to network overload
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B40i Patient Monitor and B40i Patient Monitor V3 The device
The Issue: Patient monitors may restart due to network overload
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROCARE B40 Patient Monitor
The Issue: Patient monitors may restart due to network overload
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B105/125 Patient Monitor. The device is a portable multiparameter unit
The Issue: Patient monitors may restart due to network overload
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R&D systems
The Issue: The kit was provided without a copy of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision
The Issue: Non-conformance with the DeltaVision OMX SR, the interlocks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME)...
The Issue: Firm identified an issue in the manufacturing process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Knee Instruments Disposable Fluted Headless Pins
The Issue: for outer pouch sterile barrier to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
The Issue: Boston Scientific has identified a subset of active
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROPONENT Pacemaker
The Issue: Boston Scientific has identified a subset of active
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCOLADE Pacemaker
The Issue: Boston Scientific has identified a subset of active
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ESSENTIO Pacemaker
The Issue: Boston Scientific has identified a subset of active
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston
The Issue: There is a potential for the Pacing System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
The Issue: Boston Scientific has identified a subset of active
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone
The Issue: incorrect expiration date- product is listed with 02-15-2019
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V-Twin
The Issue: The action is being initiated because the cooling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APS Accelerator modular systems
The Issue: The firm identified customer sites where modules which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Lipase Flex Reagent Cartridge
The Issue: There is lot to lot variability for QC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.