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 28101–28120 of 38,428 recalls
Recalled Item: A Picture Archiving and Communication System (PACS) intended to display
The Issue: To inform users about the possible incorrect values
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy 100
The Issue: Software Issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mobile wDR motorized portable diagnostic X-ray systems. Intended for use
The Issue: This is related to previous 806 Notifications about
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3...
The Issue: On the label calcium (Ca) listed in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CEA / CD66e Ab-2
The Issue: Certain lots of CEA/CD66e Ab2 were produced with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGION(TM) HEMI STEPPED
The Issue: The package for catalog item, a LEGION Hemi
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Battery Charger II (UBC II)
The Issue: The device is reported to enter safe mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OraQuick HCV Visual Panel Intended to assist new operation
The Issue: OraSure Technologies, Inc. discovered the package insert included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Ventilator System
The Issue: Graphical user interface (GUI) unresponsive to touch and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for
The Issue: Reports where the Mylar/Tyvek pouch for RESTORIS MCK
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jadak Barcode Scanner
The Issue: Customers reported issues when scanning medications with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.3mm Turbo-Power OTW
The Issue: The product is labeled with an expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is
The Issue: When a user performed radiography using the wireless
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BCS XP Automated Blood Coagulation Analyzer System
The Issue: False short clotting times for PT on BCS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BCS Automated Blood Coagulation Analyzer System
The Issue: False short clotting times for PT on BCS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9131-001 Defibrillation Electrodes
The Issue: Defibrillation electrodes may increase electrical impedance over time
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization...
The Issue: Water retention issues. Units with filters that remain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22
The Issue: The drug fulvestrant (Faslodex¿) may cause falsely elevated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889
The Issue: The drug fulvestrant (Faslodex¿) may cause falsely elevated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21
The Issue: The drug fulvestrant (Faslodex¿) may cause falsely elevated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.