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 26021–26040 of 38,428 recalls
Recalled Item: Guider Softip XF
The Issue: Firm became aware of potentially defective Guider Guide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci¿ Xi" Surgical System
The Issue: Intuitive Surgical has identified a software anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe
The Issue: contamination with B. cepacia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Best Practices kits containing certain production lots of Clearify Visualization
The Issue: Product sterility is compromised due to breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Clearify Visualization System Item Code: 21-345 Intended to be
The Issue: Product sterility is compromised due to breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab
The Issue: Inpeco received several notifications from the field about
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test
The Issue: .Roche Diagnostics has confirmed elevated QC and patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number
The Issue: Roche Diagnostics has confirmed elevated QC and patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SynchroMed II Implantable Drug Infusion System. This system includes:
The Issue: Medtronic is following up to a May 2013
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.0 mm Reaming Rod/950 mm w/straight Ball Tip
The Issue: The peel pouches for the affected reaming rods
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is
The Issue: Medtronic has identified an increased number of complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.0 mm Reaming Rod/950 mm
The Issue: The peel pouches for the affected reaming rods
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extraction Hook - Sterile for TI Cannulated Nails
The Issue: The peel pouches for the affected reaming rods
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.0 mm Guide Rod/950 mm with Smooth Tip
The Issue: The peel pouches for the affected reaming rods
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.5 mm Guide Rod w/Smooth Tip 950 mm
The Issue: The peel pouches for the affected reaming rods
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.5 mm Reaming Rod W/Ball Tip 650 mm
The Issue: The peel pouches for the affected reaming rods
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.5 mm Reaming Rod with Ball Tip & Extension/950 mm
The Issue: The peel pouches for the affected reaming rods
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.5 mm TI Calibrated Reaming Rod 850 mm
The Issue: The peel pouches for the affected reaming rods
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a
The Issue: The FRAX adjusted for TBS values are not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4205 Journey Rolling Walker Product Usage: used to assist people in walking
The Issue: Nova Medical is recalling the Journey Rolling Walker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.