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 12041–12060 of 38,428 recalls
Recalled Item: RUSCH Endotracheal Tube oral/nasal Magill
The Issue: The firm received reports that the endotracheal tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set
The Issue: The firm received reports that the endotracheal tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Ingenia Ambition X (Product Number 781356)
The Issue: The sealed magnet will experience uncontrolled shutdown known
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pneupac paraPac plus 300 ventilator kit
The Issue: Two devices were labeled with the same serial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Normand Remisol Advance Data Manager
The Issue: There is a potential that the data management
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cell Marque Antibodies
The Issue: Mouse Monoclonal Antibody labelled with an incorrect expiry
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i
The Issue: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One
The Issue: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLASH Ostial System
The Issue: Angioplasty system has a manufacturing issue that has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew BHR SQUARE HEADED NAIL
The Issue: The nail head may become detached during surgery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water
The Issue: There is the potential for contaminated water to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EV3 Pipeline Flex Embolization Device with Flex Shield Technology
The Issue: Due to potential push wire fractures in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pipeline Flex Embolization Device
The Issue: Due to potential push wire fractures in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON Juniper Diagnostic Ultrasound System
The Issue: Due to intermittent failures of the power supply
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gore Molding & Occlusion Balloon Catheter
The Issue: Complaints received concerning Balloon Catheter leakage from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity s System . An automated immunoassay analyzer for
The Issue: A design defect (hardware and software) allows liquid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic...
The Issue: Deterioration in the stability of the reagents which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
The Issue: Deterioration in the stability of the reagents which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
The Issue: Deterioration in the stability of the reagents which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
The Issue: Deterioration in the stability of the reagents which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.