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 19141–19160 of 38,428 recalls
Recalled Item: GE Healthcare Centricity Universal Viewer Breast Imaging Centricity...
The Issue: When switching back & forth between multiple UV
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoaguChek XS PT Test
The Issue: for abnormally high INR test results with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity i Processing Module
The Issue: Abbott has identified an issue with the Alinity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fungitell Kit
The Issue: The kits may contain the incorrect number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Durex Pleasure Pack (60 ct)
The Issue: Five batches of the product have failed the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Durex Real Feel
The Issue: Five batches of the product have failed the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Entuit Secure Gastrointestinal Suture Anchor Set
The Issue: There is a potential for difficulty in sliding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Entuit Secure Gastrointestinal Suture Anchor Set
The Issue: There is a potential for difficulty in sliding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC
The Issue: This recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stingray" Guidewire
The Issue: A batch of 185cm Stingray Guidewires are incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemotherm CE Dual Reservoir Cooler/Heater
The Issue: Evidence supports that when customers performed a fuse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity TF PET/CT (non-RoHS)
The Issue: A software update is being issued to correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARJOHUNTLEIGH GETINGE GROUP
The Issue: Inability or difficulty in unbuckling/releasing the proning arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
The Issue: Product was packaged with the Incorrect tamper proof
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnipod DASH Insulin Management System
The Issue: There is a potential for a communication interruption
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x
The Issue: Argon Medical has identified an internal manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
The Issue: Argon Medical has identified an internal manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: J Type Bone Marrow Needle 13ga x 6cm - Product
The Issue: Argon Medical has identified an internal manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x
The Issue: Argon Medical has identified an internal manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: J Type Bone Marrow Needle 13ga x 10 cm- Product
The Issue: Argon Medical has identified an internal manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.