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 12141–12160 of 38,428 recalls
Recalled Item: AltiVate Anatomic Shoulder System for the following Part Numbers: 1.
The Issue: Complaints have been received concerning the humeral stem
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KeyPrint Soft- bottle
The Issue: Product label intended for the European community was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CUTTING ELECTRODE BIPO 24.5FR
The Issue: Product labeled as Cutting Electrode may contain BIVAP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTI SARS-CoV-2 RT-PCR Test
The Issue: The firm identified a precipitation issue which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS
The Issue: patient exposure to the graphite substrate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusomat Space Volumetric Pump Administration Set
The Issue: There is a potential for the Anti-free flow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioQuip
The Issue: There is the potential bacterial including Nontuberculous mycobacterial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMX Navigate Mobile X-Ray System
The Issue: An unexpected column motion while attempting to park
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas infinity central lab running software version 3.01.03 through 3.02.08
The Issue: Under specific circumstances created by the user, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
The Issue: Major errors (Resistant result instead of Susceptible result)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow...
The Issue: Due to complaints received regarding incomplete/open packaging seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen...
The Issue: Due to complaints received regarding incomplete/open packaging seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kaluza C Flow Cytometry Software Versions: 1.0*
The Issue: Software anomalies that may lead to the generation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm
The Issue: Due to complaints received regarding incomplete/open packaging seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Sonicision Reusable Generator-converts electrical power from the...
The Issue: for a manufacturing assembly error-may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MYLA software. Used to manage microbiology test workflow from the
The Issue: Software anomaly - Under certain conditions, unwanted alterations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: muRata Vios Monitoring System Model 2050
The Issue: During the set-up and workflow to begin Vios
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Configura Advance Chair
The Issue: The firm has identified a potential for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEO DELTA Self Safe
The Issue: Problems related to the sterilization of the medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEO DELTA Self Safe 1
The Issue: Problems related to the sterilization of the medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.