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 27381–27400 of 38,428 recalls
Recalled Item: Confocal GI Scope Intended to provide optical visualization of an
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Choledochoscope Intended to provide optical visualization of and therapeutic...
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gastroscope Intended to provide optical visualization of and therapeutic access
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of
The Issue: Pentax has become aware that operational/cleaning accessories and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System
The Issue: Ortho Clinical Diagnostics confirmed a software timing anomaly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 3600 Immunodiagnostic System
The Issue: Ortho Clinical Diagnostics confirmed a software timing anomaly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZ Slide Battery/line powered hydraulic table with removable leg section
The Issue: The potential exists within the identified tables that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nuvectra
The Issue: If used, the optional Swap feature copies programming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2:
The Issue: During internal studies using contrived plasma specimens, several
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Germ Terminator
The Issue: CEG Enterprises, LLC is recalling Germ Terminator Toothbrush
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for
The Issue: Testing of retained units indicated that Lot numbers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC)
The Issue: Testing of retained units indicated that Lot numbers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Masimo SPO2 Sensor
The Issue: Under certain conditions, the cables used with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014)
The Issue: Under certain conditions, the cables used with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor
The Issue: Under certain conditions, the cables used with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MasimoSET LNOP DCI adult SpO2 reusable sensor
The Issue: Under certain conditions, the cables used with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Eye Station and Merge Eye Care PACS.
The Issue: During an antivirus program scan of the Eye
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Hemo software. The firm name on the labeling is Merge Healthcare
The Issue: Use of the software may show an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iConnect Enterprise Archive (ICEA) software. The firm name on the
The Issue: An error message can occur resulting in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Eye Care Systems
The Issue: The system will completely stop allowing the downloading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.